[Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
[Rules and Regulations]
[Pages 27183-27193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 806
[Docket No. 91N-0396]
Medical Devices; Reports of Corrections and Removals
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to establish procedures for implementing the reports of corrections and
removals provisions of the Safe Medical Devices Act of 1990 (the SMDA)
by requiring that manufacturers, importers, and distributors report
promptly to FDA any corrections or removals of a device undertaken to
reduce a risk to health posed by the device or to remedy a violation of
the Federal Food, Drug, and Cosmetic Act (the act) caused by the device
which may present a risk to health. FDA believes that this action is
necessary to protect the public health by ensuring that the agency has
current and complete information regarding those actions taken to
reduce risks to health caused by the devices. Reports of such actions
will improve the agency's ability to evaluate device-related problems
and to take prompt action against potentially dangerous devices.
DATES: Effective November 17, 1997. Submit written comments on the
information collection provisions of this final rule by July 18, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-827-2970.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's reporting and recordkeeping requirements for medical devices
reflect a series of amendments to the act (21 U.S.C. 321-394) as
follows: (1) The Medical Device Amendments of 1976 (Pub. L. 94-295)
(the 1976 amendments) which amended the act to establish the first
comprehensive framework for the regulation of medical devices; (2) the
SMDA (Pub. L. 101-629), which amended the act to correct noted problems
with the implementation and enforcement of the 1976 amendments; and (3)
The Medical Device Amendments of 1992 (Pub. L. 102-300) (the 1992
amendments), which amended certain provisions of the act relating to
devices.
Section 519(f) of the act (21 U.S.C. 360i(f)), as added by the
SMDA, authorizes FDA to issue regulations to require reports and
recordkeeping of correction and removal actions taken by device
manufacturers, distributors, and importers. Under the final rule, a
correction means the repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a device
without its physical removal from its point of use to some other
location. Removal means the physical removal of a device from its point
of use to some other location for repair, modification, adjustment,
relabeling, destruction, or inspection.
Under section 519(f)(1) of the act, device manufacturers,
distributors, and importers are to report promptly to FDA any
correction or removal of a device undertaken: (1) To reduce a risk to
health posed by the device; or (2) to remedy a violation of the act
caused by a device which may present a risk to health. Section
519(f)(1) of the act also requires manufacturers, distributors, and
importers to keep records of those corrections and removals that are
not required to be reported to FDA. Section 519(f)(2) of the act
provides that no report of a correction or removal action under section
519(f)(1) may be required if a report of the correction or removal
action is required and has been submitted to FDA under section 519(a),
which prescribes rules for reporting and keeping records of certain
significant device-related events. Section 519(f)(3) of the act states
that the terms ``correction'' and ``removal'' do not include routine
servicing.
The final rule provides a mechanism for FDA to receive timely
information about potentially dangerous marketed devices by requiring
device manufacturers, distributors, and importers to report promptly to
FDA any correction or removal of a device undertaken to reduce a risk
to health posed by the device, or to remedy a violation of the act
caused by the device which may present a risk to health. Section 519(f)
of the act was enacted because Congress was concerned that device
manufacturers, distributors, and importers were carrying out product
corrections or removals without notifying FDA, or without notifying the
agency in a timely fashion (H. Rept. 808, 101st Cong., 2d sess. 29
(1990)). Congress explained that industry's failure to report
corrections and removals, particularly those undertaken to reduce risks
associated with the use of a device, ``denies the agency the
opportunity to fulfill its public health responsibilities by evaluating
device-related problems and the adequacy of corrective actions'' (S.
Rept. 513, 101st Cong., 2d sess. 23 (1990)), and ``has seriously
interfered with FDA's ability to take prompt action against potentially
dangerous devices'' (H. Rept. 808, 101st Cong., 2d sess. 29 (1990)).
The agency recognizes that Congress did not want to overburden
industry or FDA with excessive reporting
[[Page 27184]]
requirements and that the reporting requirements apply to the ``more
important postmarket actions, excluding those events already reported
to the [agency].'' (S. Rept. 513, 101st Cong., 2d sess. 23 (1990)). To
ensure that FDA has access to all relevant information on corrections
and removals, Congress provided that records be maintained for those
corrections and removals that need not be reported.
II. Highlights of the Final Rule
The agency has revised and clarified certain provisions of the
final regulation. Further, the agency has narrowed the scope of the
regulation to focus more explicitly on those corrections and removals
that address more serious risks to health. The most significant changes
from the March 23, 1994, proposed rule (59 FR 13828) to establish
procedures to implement the reports of corrections and removals
provisions of section 519(f) of the act (hereinafter referred to as the
March 1994 proposed rule) follow:
1. The definition of ``risk to health'' has been narrowed by
revising Sec. 806.2(j) to focus explicitly on those corrections and
removals undertaken to mitigate the potential for adverse health
consequences. The revised definition of ``risk to health'' tracks the
definitions of class I and class II recall in Sec. 7.3(m) (21 CFR
7.3(m)).
2. Section 806.10(e) has been added to allow a device manufacturer,
importer, or distributor to disclaim that the submission of a required
report of correction or removal is an admission that the device caused
or contributed to a death or serious injury.
3. Section 806.10(f) has been added to state clearly that a
remedial action that is required and has been reported to the agency
under part 803 (21 CFR part 803) (Medical Device Reporting), 21 CFR
part 804 (Distributor Reporting), or part 1004 (21 CFR part 1004)
(Repurchase, Repairs, or Replacement of Electronic Products) does not
have to be resubmitted to the agency as a correction or removal report.
4. FDA has added the definition of ``market withdrawal'' at
Sec. 806.2(h) and has amended Sec. 806.1(b)(2) to make clear that
market withdrawals are not reportable events.
5. The requirement in Sec. 806.10(b) to submit reports within 10-
calendar days of initiating a correction or removal has been changed to
10-working days.
6. The agency has established an effective date of 180 days after
publication of the final regulation for submission of reports of
corrections and removals.
7. The definition of ``U.S. designated agent'' has been deleted.
FDA is reconsidering the duties of foreign manufacturers with respect
to reporting under this rule and under part 803 and may propose a new
rule to address this issue in the future.
FDA believes that with these revisions, the final rule incorporates
reasonable requirements that can be implemented by the regulated
industry without unnecessary burden.
III. Summary and Analysis of Comments and FDA's Response
The March 1994 proposed rule proposed to establish procedures to
implement the reports of corrections and removals provisions of section
519(f) of the act. FDA received 33 comments and 2 requests for an
extension of the comment period in response to the March 1994 proposed
rule. This total number represents comments received from
manufacturers, distributors, trade associations, attorneys, and one
hospital. For the most part, each comment addressed various aspects of
the March 1994 proposed rule. Several of the comments stated that the
March 1994 proposed rule was overly broad in scope, required the
submission of unnecessary data, and imposed undue burdens on FDA and
industry. Several comments also cited FDA's failure to address in the
preamble the voluntary recall regulation, which was published in the
Federal Register of June 16, 1978 (43 FR 26202), and the medical device
reporting (MDR) regulation, which was published in the Federal Register
of December 11, 1995 (60 FR 63578). Some of the comments stated that
the definitions of certain regulatory terms lacked clarity. Other
comments expressed concern regarding public disclosure of trade
secrets, and confidential commercial and financial information in
reports of corrections and removals submitted to FDA. FDA did not
extend the comment period. The comments and FDA's responses are
summarized below.
1. Several comments stated that the proposed requirements for
reports of corrections and removals should clarify the relationship
between the reports of corrections and removals regulation and FDA's
voluntary recall policy in part 7 (21 CFR part 7). FDA notes that the
recall policy (including product corrections) in part 7 was not
addressed in the preamble to the March 1994 proposed rule.
In the voluntary recall regulation, FDA established the agency's
policy and procedures for voluntary product recalls. This final notice
was intended to provide guidance to manufacturers and distributors of
all products regulated by FDA so that they could more effectively
discharge their recall responsibilities. The voluntary guidelines apply
to all FDA-regulated products (i.e. food, including animal feed; drugs;
medical devices, including in vitro diagnostic products; cosmetics; and
biological products intended for human use) except electronic products
subject to the Radiation Control for Health and Safety Act (RCHSA)
(Pub. L. 90-602) that are not medical devices, and may be undertaken at
any time by manufacturers and distributors, or at the request of FDA.
These voluntary guidelines remain in effect and will supplement the
reports of correction and removal provisions of section 519(f) of the
act. If a report of correction or removal is required under part 806
(21 CFR part 806), it must be submitted as provided in Sec. 806.10. If
a report is not required under part 806, an entity may voluntarily
report under part 7. The definition of ``risk to health'' in this rule
(Sec. 806.2(j)) tracks the definitions of class I and class II recall
in Sec. 7.3(m). The effect of using the same language in part 806 is to
require reports of corrections and removals for class I and class II
recalls. Under part 806, manufacturers, importers, and distributors
must keep records of events categorized as class III recalls under part
7.
Section 518(e) of the act (21 U.S.C. 360h(e)) provides FDA with the
authority to initiate mandatory recall actions if there is a reasonable
probability that a device intended for human use would cause serious
adverse health consequences or death. In the Federal Register of
November 20, 1996 (61 FR 59004), FDA published a final rule requiring
recall of medical devices under some circumstances. Any corrective or
removal action initiated by an FDA order under section 518(e) of the
act need not be reported under part 806 because FDA will already be
aware that the action is taking place. In such cases, reporting or
notification requirements of the section 518(e) order and the recall
regulation will be applicable.
2. Comments stated that this rule duplicates the requirements of
the MDR regulation (part 803). Other comments stated that it is unclear
which events should be reported under the MDR regulation.
FDA agrees that the relationship between this final rule and the
MDR regulation warrants clarification so as to avoid unnecessary
duplication. Indeed, section 519(f)(2) of the act prohibits FDA from
requiring a report of correction or removal, if that same
[[Page 27185]]
information has been required and has been submitted under MDR.
Generally, there is expected to be little overlap between these
reporting requirements. This is because MDR's are based on adverse
events that have occurred (i.e., deaths, serious injuries, and
malfunctions) regardless of whether a remedial action (i.e., correction
or removal) has been undertaken by the manufacturer or distributor.
Moreover, the MDR report, which is tied to the adverse event itself and
its possible association with the device, will only rarely address any
remedial action taken by the manufacturer because, in most cases, no
such remedial action has yet occurred.
The primary area where such overlap between the final rule and MDR
would be expected is with the 5-day MDR report. This is because 5-day
MDR reports are required within 5 days of the submitter becoming aware
that an MDR reportable event (i.e., death, serious injury, or
malfunction) requires remedial action to prevent an unreasonable risk
of substantial harm to the public health (Sec. 803.55). Thus, by
linking the 5-day MDR reports to the need for remedial action,
information concerning the correction or removal will necessarily be
submitted under MDR and will not need to be resubmitted under part 806.
FDA has modified the final rule to reflect this (Sec. 806.10(f)).
In addition, in those rare cases where the routine MDR reports
submitted to FDA (30-day reports for manufacturers and 10-day reports
for distributors) are required to and do contain information on the
remedial actions taken (i.e., corrections or removals), then no
additional report under this final rule needs to be submitted to the
agency.
FDA notes that, under regulations issued to implement the RCHSA,
the equivalent of a report of a correction or removal is required under
part 1004 for electronic products which may also be medical devices.
Part 1004 requires that, if an electronic product has a defect or fails
to meet an applicable Federal performance standard, the manufacturer
shall, repair, replace, or refund the cost of the electronic product.
Devices for which Federal standards are currently in place under the
RCHSA include x-ray equipment, fluoroscopy equipment, magnetic
resonance imaging devices, medical lasers, and ultrasound devices.
FDA believes that the information that is required by part 1004 is
sufficient notice to FDA of a correction or removal. Furthermore,
manufacturers of these products are familiar with the reporting
requirements of part 1004. Therefore, on its own initiative, FDA is
modifying Sec. 806.10(e) to state that, if a report is required and is
submitted under part 1004 for a correction or removal that would
otherwise be required to be reported under part 806, no report under
part 806 is required.
3. Comments questioned FDA's authority to review any correction or
removal report to determine if the correction or removal action should
be extended to other units of the same device, other products of the
same manufacturer or distributor, or similar products of other
manufacturers and distributors.
FDA believes that it is appropriate and necessary, and in the
interest of the public health, for FDA to review reports of corrections
and removals to determine if any further remedial action such as a
recall or safety alert is required, and to further determine if there
is a need to extend the correction or removal action to other units of
the same device, other products of the same manufacturer, distributor,
or importer, or similar products of other manufacturers, distributors,
or importers, which may present a similar risk to health.
4. Some of the comments received in response to the March 1994
proposed rule for reports of corrections and removals stated that
manufacturers of general purpose articles, such as chemical reagents
and laboratory equipment, are not subject to medical device
regulations.
Under Sec. 807.65(c) (21 CFR 807.65(c)), general purpose articles
whose uses are generally known by persons trained in their use, unless
labeled or promoted for medical use, are exempt from registration,
listing, and premarket notification requirements. However, unless
exempted by regulation, general purpose articles that are medical
devices are subject to section 519(f) of the act and to the
requirements of this rule.
The March 1994 proposed rule at Sec. 806.1(b)(3) exempted certain
actions undertaken by manufacturers of general purpose articles that
were already exempted from reporting under Sec. 806.1(b)(1). The
exemption that formerly appeared at Sec. 806.1(b)(3) does not appear in
the final rule because it is redundant and unnecessary.
5. Comments objected that the March 1994 proposed rule does not
differentiate removals done solely upon customer request from other
removals.
Removals done solely upon customer request (i.e., overstock,
discontinued use of the item, order error, old stock, not current
design, or perceived issues with specific lots) that are not performed
to reduce a risk to health posed by the device, or to remedy a
violation of the act caused by the device that may present a risk to
health, are not removals within the meaning of section 519(f)(1) of the
act. FDA has amended Sec. 806.2 to include the definition of ``market
withdrawal'' and Sec. 806.1(b)(2) to make clear that market withdrawals
are not reportable events. The definition of market withdrawal in
Sec. 806.2(h) tracks the definition in the voluntary recall provisions
in Sec. 7.3(j). The example in Sec. 7.3(j) of ``routine equipment
adjustments and repairs'' is not included in new Sec. 806.2(h) because
it would be redundant to the definition of ``routine servicing'' in
Sec. 806.2(k).
6. Comments stated that it would be redundant to require
convenience kit manufacturers to report when the supplier of the
component initiates a correction or removal; to do so would be
redundant and no additional value would be added to the process.
FDA agrees that duplicate reports would be redundant, but disagrees
that the rule requires duplicate reports. Only the person who initiates
the correction or removal is required to report.
7. Comments stated that the manufacturer should not be required to
report if a manufacturer discovers after removing or correcting a
medical device that the device did not pose a risk to health or that
the risk posed was no greater than the risk described on the labeling
of the device.
A manufacturer, distributor, or importer that initiates a
correction or removal of a device to reduce a risk to health or remedy
a violation of the act that could present a risk to health must submit
a report to FDA within 10-working days of initiation of the action. In
most cases, if the action has been completed, it should have been
reported. The only way the action would be exempt from reporting within
the required 10-working days is if it was determined by the
manufacturer, distributor, or importer during that 10-day period that
the device did not present a risk to health, or there was no violation
of the act that could present a risk to health. After a report is
received by the agency, if FDA determines that there is no health risk,
or violation of the act that could present a risk to health, FDA would
not classify the action as a safety alert or as a recall under part 7,
but more likely as a market withdrawal.
8. Comments stated that distributors may not have the capacity to
make the determination as to whether a given action is reportable.
Other comments suggested that the reports of corrections and removals
should not apply to drug wholesalers that distribute devices
[[Page 27186]]
because they have neither the authority nor the expertise to determine
health risk or to undertake any corrections or removals of a
manufacturer's product. Some comments stated that the definition of
distributor in the March 1994 proposed rule is too broad.
It is clear from the statute that Congress intended that
distributors be required to submit reports of corrections and removals
if they initiate a correction or removal action. The agency believes
that the definition of distributor in Sec. 806.2(f) is sufficient.
Narrowing this definition would prevent the agency from monitoring
corrective action taken concerning adulterated or misbranded devices.
9. Comments objected that routine reporting by distributors would
disproportionately utilize the agency's resources.
Section 519(f) of the act only requires distributors to report
corrective or removal actions if they initiate the action and only one
report for each correction or removal is required. Therefore, FDA does
not believe that distributor reporting will disproportionately use the
agency's resources.
10. Comments said that device rental companies should be defined as
multiple distributors and not manufacturers.
The rule does not define rental companies as manufacturers. Rather,
companies that rent devices would fall within the definition of
``distributor'' (Sec. 806.2(f)) for the purposes of this rule.
Manufacturers and distributors are subject to the same requirements
under this rule to report and keep records of corrections and removals
initiated by them.
11. Some comments stated that the scope of the March 1994 proposed
rule for reports of corrections and removals should apply to entities
that refurbish or recondition a device for resale.
Under section 519(f) of the act, the requirement for reporting
corrections and removals applies to any manufacturer, importer, or
distributor of a device, which would include a refurbisher and a
reconditioner. Accordingly, if a refurbisher or refinisher of a device
initiates a correction or removal, that refurbisher or reconditioner is
responsible for reporting under part 806.
12. Some comments stated that the reports of corrections and
removals regulation should be written to exclude some medical devices
which clearly pose no threat to the safety of the patient in case of
label mixups.
FDA believes that the request to exclude some medical devices which
clearly pose no threat to the safety of the patient in case of label
mixups is neither appropriate nor necessary. If a label mixup does not
present a risk to the public health, no report is required.
13. Comments suggested that the proposed regulation should be
narrowed so as to focus more explicitly on those removals and
corrections undertaken to mitigate the potential for serious illness or
serious injury. Other comments stated that the threshold for reporting
corrections and removals is too low.
The agency believes that it is appropriate to narrow the scope of
the regulation to focus more explicitly on those corrections and
removals initiated to mitigate the potential for adverse health
consequences. As discussed elsewhere in this regulation, FDA has
revised the definition of ``risk to health'' (Sec. 806.2(j)) to enable
the agency to focus its resources on more significant health problems.
14. Comments said that FDA should add the following explicit
examples of potential corrections and removals that are not intended to
reduce a risk to health posed by the device or remedy a violation of
the act: (1) When no injury has been, or is likely to be, associated
with the event; (2) when a product has reached the end of its useful
life; (3) when a device is returned to its original specifications due
to extensive use; (4) when no cause for the device failure can be found
following failure investigation; (5) where the withdrawal is for the
purpose of retracting a new product line and/or upgrading the device to
a more recent version; (6) where a request is made to return product
for a complaint or MDR evaluation; or (7) when a device from a batch/
lot is needed to aid in the investigation of a complaint about the same
batch/lot.
The agency believes that it is not necessary to provide explicit
examples of potential reports of corrections and removals that are not
intended to reduce a risk to health posed by the device or remedy a
violation of the act caused by the device that may present a risk to
health. A firm may routinely correct or remove its devices in the
marketplace or under its control for various reasons other than to
reduce a risk to health or remedy a violation of the act that may
present a risk to health. However, in response to these comments, FDA
has added the definition of ``stock recovery'' at Sec. 806.2(l) and
exempted actions meeting this definition from the reporting
requirements at Sec. 806.1(b)(4). The definition of ``stock recovery''
in Sec. 806.2(l) tracks the definition in the voluntary recall
provisions in Sec. 7.3(k). Only actions taken by a manufacturer can
meet the definition of ``stock recovery.''
15. Comments said that the scope of the March 1994 proposed rule
should be broadened to include a definition of ``device enhancement''.
The agency does not believe that it is necessary to define ``device
enhancement''. If a correction or removal is initiated in order to
enhance a device in the absence of a risk to health, no report is
required. The central question is whether there is a risk to health and
not whether the device is enhanced. Section 806.1(b) makes it clear
that an action taken to improve a device in the absence of a risk to
health is not a reportable event.
16. Comments said that the requirement that only one report be
submitted for each reportable event means that a reportable event is a
specific correction or removal program for a defined population of
devices rather than a correction or removal of an individual device.
Other comments said that the proposed regulation appears to require
reporting whenever a particular device is inspected, adjusted, or
repaired in an identical way more than once even when the triggering
events are random, are separated in time, and no program of repair or
correction is in progress or is needed.
FDA agrees that generally, a single correction or removal that
involves more than one device requires only one report. However, when
the triggering events for removals or corrections are the same but are
separated in time, for example, when consecutive lots of a product with
the same defect are not released at the same time, separate reports
will have to be made for each event unless the timing is such that more
than one event can be reported at once, given the time period for
reporting in this regulation. FDA encourages manufacturers,
distributors, and importers to consider whether it would be appropriate
to extend removal or corrective actions performed in response to one
event to other units of the same device or similar devices and, in some
cases, this type of investigation may be required under part 820 (21
CFR part 820). If multiple repairs of the same or similar devices are
undertaken as part of a program of repair, the triggering incident and
the entire program of repair can be submitted as one report. The agency
will require amendments when additional devices, lots, and batches are
being added to the same corrections or removal. This approach provides
a more efficient and effective procedure for reporting actions that
should be considered together. FDA has
[[Page 27187]]
added a new Sec. 806.10(d) to provide for the submission of such
amendments.
17. One comment states that a ``bug list'' distributed by device
manufacturers to customers advising them of problems associated with
software equipment used to run work stations could be considered a
correction to software.
A manufacturer, importer, or distributor that undertakes a
corrective or removal action for computer software that is considered a
medical device must submit a report of such action to FDA. If the
action is taken to reduce a risk to health or to remedy a violation of
the act that could present a risk to health caused by computerized
software that comes within the definition of a device, a report must be
submitted; however, it is not likely that a ``bug list'' would be
considered a removal. A ``bug list'' could be considered a correction
if it constitutes relabeling, but again, would only be reportable if it
was undertaken to reduce a risk to health or to remedy a violation of
the act that could present a risk to health.
18. Some comments stated that the definition of risk to health was
too broad; that the definition of ``risk to health'' should not include
the terms ``or error in the use of the device''; that the definition of
``risk to health'' should include ``error in the use of the device'';
and that to impose these additional documentation and reporting
requirements upon manufacturers adds a significant regulatory burden.
FDA agrees that the definition of risk to health in the March 1994
proposed rule is too broad. The agency has revised the definition of
``risk to health'' at Sec. 806.2(j) to mean (1) a reasonable
probability that the use of, or exposure to, the product will cause
serious adverse health consequences or death, or (2) that use of, or
exposure to, the product may cause temporary or medically reversible
adverse health consequences, or an outcome where the probability of
serious adverse health consequences is remote. The practical effect of
adopting this revised definition is to require reports of removals and
corrections for those corrective actions that would be classified as
class I or class II recalls under Sec. 7.3(m). Moreover, the agency
intends for ``serious adverse health consequences'' to have the same
meaning as ``serious injury'' under the MDR rule. At Sec. 803.3(aa)(1),
the MDR rule defines serious injury to mean an illness or injury that
(1) is life-threatening; (2) results in permanent impairment of a body
function or permanent damage to a body structure; or (3) necessitates
medical or surgical intervention to preclude permanent damage to a body
structure.
This definition allows FDA to allocate its resources efficiently
and precludes an unnecessary burden on manufacturers of reporting
requirements for extremely remote, trivial risks to the public health.
However, a correction or removal undertaken to alleviate a risk to
health as defined by Sec. 806.2(j) must be reported under this section
even if caused by user error. Reports about corrections or removals
based on user error are important to FDA's ability to evaluate the
problems with devices and to take prompt action against potentially
dangerous devices.
19. Comments said that the phrase ``to remedy a violation of the
act caused by the device which may present a risk to health'' should be
further clarified.
Action taken to remedy a violation of the act means any action
taken to bring a device that was not in compliance with any provision
of the act into compliance or to prevent a noncompliance before it
occurs.
20. Comments said that the definitions of the terms ``correction''
and ``removal'' are overly broad and would require reports to FDA of
thousands of service reports when a medical device is repaired.
Further, comments said that the definition of routine servicing is
extremely vague and open to subjective interpretation, while others
said that this definition was overly restricted and unrealistic.
FDA believes that the definitions of the terms ``correction'' and
``removal'' are appropriate in scope. It is important to emphasize
that, under the final rule, a report to FDA is required only when a
specific action is taken to reduce a risk to health or to remedy a
violation of the act that could result in a risk to health. Section
519(f)(3) of the act states that the terms ``correction'' and
``removal'' do not include routine servicing. As defined in
Sec. 806.2(k) an action is considered ``routine servicing'' if it is
conducted in accordance with a maintenance schedule for a device, or if
it is a repair, adjustment, or replacement of parts in response to
normal wear and tear of a device. An action is required to be reported
only if it is specifically initiated to reduce a risk to health or
remedy a violation of the act that could result in a risk to health.
Under Sec. 806.1(b)(2), routine servicing is exempt from the reporting
requirements of this regulation.
21. Comments said that the definition of consignee is overly broad.
FDA does not agree with these comments. FDA believes that the
definition of ``consignee'' should be sufficiently broad to protect the
public health. A correction or removal need only reach the level of
consignee appropriate for the situation.
22. A comment said that FDA should clarify the definition of ``U.S.
designated agent''.
The term ``U.S. designated agent'' was first introduced in the MDR
regulation (Sec. 803.3(n)). In the Federal Register of July 23, 1996
(61 FR 38346), FDA stayed the effective date of the U.S. designated
agent provisions of the MDR rule and announced that it intended to
reconsider reporting by foreign manufacturers and issue a new proposal
in the near future. In keeping with that announcement, FDA has deleted
the definition of ``U.S. designated agent'' that appeared in the March
1994 proposed rule at Sec. 806.2(g)(4), from the reports of corrections
and removals regulation. Foreign firms meeting the definition of
``manufacturer,'' ``distributor,'' or ``importer'' are responsible for
submitting their own reports of corrections and removals involving
devices imported into the United States. Failure to do so will result
in their devices being adulterated under section 502(t) of the act (21
U.S.C. 352(t)) and may cause their devices to be refused admission for
import under section 801(a) of the act (21 U.S.C. 381(a)).
23. One comment stated that FDA should make the recordkeeping
requirements advisory rather than mandatory. Another comment stated
that the preamble is confusing in that it implies without stating that
entities must supply justification for when reporting is not required.
FDA disagrees with these comments. Section 519(f) of the act
directs FDA to issue regulations to require reporting and recordkeeping
of correction and removal actions. Section 519(f)(1) of the act
requires manufacturers, distributors, and importers to keep records of
those corrections and removals that are not required to be reported to
FDA (see S. Rept. 513, 101st Cong., 2d sess. 23 (1990)). Section
806.20(c)(4) requires explicitly that entities include the
justification for not reporting a correction or removal in the records
required by this rule. These records will be used by FDA to audit the
manufacturer's determination that a report of correction or removal was
not required. Similarly, Sec. 820.198 requires manufacturers to keep
records of evaluations of complaints whether or not they are reportable
under the MDR regulation.
24. Several comments stated that the 10-calendar days in
Sec. 806.10(b) within which to submit a report of a correction or
removal is not enough time. Some
[[Page 27188]]
comments stated that the agency should clarify when a correction or
removal is considered to be ``initiated''.
FDA agrees with these comments. In order to allow sufficient time
for preparation of complete reports, FDA has extended the reporting
period to 10-working days. This will allow for a sufficient time for
reporting when holidays or weekends intervene. However, the agency
recognizes that, on rare occasions, a manufacturer or distributor will
not be able to gather all the information required by Sec. 806.10 to
complete a report. Therefore, FDA has revised the regulation by
including Sec. 806.10(b)(13) to allow manufacturers and distributors to
identify information that is not available, provided that they state
when it will be available.
Although the SMDA does not specifically define the term
``initiation'' or ``initiating'', FDA believes that the initiation or
initiating of a correction or removal is that moment in time when a
firm makes the first contact within or outside the firm that begins the
correction or removal action.
25. One comment stated that the information manufacturers would be
required to report is far in excess of that which FDA needs for a
reporting program, especially in light of the many other controls and
reporting programs already in effect that require companies to maintain
records and/or make reports about the same type of information. Another
comment stated that the criteria for submission of reports of
corrections and removals are too subjective and may be difficult to
apply in actual practice.
FDA agrees with these comments and, as noted above, has narrowed
the definition of ``risk to health.'' The final rule, as revised,
applies basically the criteria for class I and class II recalls used
successfully by FDA for more than 20 years under part 7.
26. One comment stated that a form for reporting corrections and
removals would be useful, particularly if it served as a checklist of
required information but allowed flexibility in providing the
information. The comment also stated that it would be helpful if
electronic or disc submissions were possible. One comment stated that a
form would be impractical as it would not allow the flexibility
necessary to accommodate various needs. One comment developed and
submitted a form for use by the agency.
In the March 1994 proposed rule, FDA solicited comments regarding
whether it would be desirable to develop a form to collect reports of
correction and removal data. FDA has determined that a form is not
necessary. FDA believes that industry and the agency have more
flexibility without a form without sacrificing good information
management practices.
In the Federal Register of March 20, 1997 (62 FR 13430), FDA
published a final rule that will, under certain circumstances, permit
the submission of electronic records, electronic signatures, and
handwritten signatures executed to electronic records as generally
equivalent to paper records and handwritten signatures executed on
paper. The rule will apply to records that are called for in title 21
of the Code of Federal Regulations (CFR) when submitted in electronic
form. The intended effect of the March 1994 proposed rule is to permit
use of electronic technologies in a manner that is consistent with
FDA's overall mission and that preserves the integrity of the agency's
enforcement activities.
27. One comment stated that a manufacturer may be admitting product
liability if the manufacturer is required to submit a report for a
correction or removal of a device when the regulation requiring the
report is based upon ``risk to health''. The comment stated that the
proposed regulation should be amended to allow a manufacturer to
disclaim the admission of risk to health associated with a device by
the mere submission of this required report.
In response to the comment, FDA has added Sec. 806.10(e) to the
final rule stating that a report of information submitted by a
manufacturer, distributor, or importer (and any release by FDA of that
report or information) does not necessarily reflect a conclusion by the
manufacturer, importer, distributor, or FDA that the report or
information constitutes an admission that the device caused or
contributed to a death or serious injury. A manufacturer, distributor,
or importer need not admit, and may deny, that the report or
information submitted under this section constitutes an admission that
the device caused or contributed to a death or serious injury.
28. Some comments stated that the term ``complete'' is subjective
and should be deleted from Sec. 806.10(c)(7), which required ``A
complete description of the event(s) giving rise to the information
reported and the corrective or removal actions that have been, and are
expected to be, taken'' (emphasis added), and Sec. 806.20(b)(3), which
required ``A complete description of the event giving rise to the
information reported and the corrective or removal action that has
been, and is expected to be taken.''
FDA agrees with these comments. The term ``complete'' has been
deleted from these sections of the regulation.
29. One comment stated that the word ``inspection'' should be
deleted from the definition of correction. According to this comment,
the act of inspecting is not, per se, an event which corrects a device.
The comment said that, while an action of correction could result from
an inspection event, the process of determining if a correction is
warranted should not be a reportable event under part 806.
FDA agrees an inspection that is conducted before a determination
that a public health risk exists is not a reportable event. However,
FDA believes that an inspection that is initiated as a result of a
public health risk is a correction. The term ``inspection (including
patient monitoring)'' is included in the definition of ``correction''
in Sec. 7.3. FDA has in the past classified firms' inspections that
were conducted to determine which device contained a defective
component as recall actions, especially when a firm failed to maintain
adequate records to determine which devices were manufactured with a
possible defect, or which consignees received defective devices.
30. Some comments stated that the proposed requirement with regard
to the number scheme for ``C'' (correction) and ``R'' (removal) type
reports is not clear. Another comment stated that FDA has exceeded the
scope of its statutory authority in mandating a specific reporting
format for reports of corrections and removals. Other comments stated
that manufacturers should be provided with the option of designating
their own report numbers. Another comment stated that requiring the
creation of an 18 character alpha-numeric field for computer data bases
to identify, track, and retrieve associated information in the
correction or removal report number section adds unnecessary additional
requirements to the recordkeeping task for manufacturers, and that
perhaps the existing unique sequence number that each manufacturer uses
to identify their product complaints should be adequate.
FDA believes that the number scheme for ``C'' (corrections) and
``R'' (removal) type reports should be clarified, and has clarified the
numbering system in Sec. 806.10(c)(1). FDA does not believe that it has
exceeded its statutory authority. A uniform numbering system for
reports of corrections and removals will assist the agency, in filing,
organizing, and retrieving reports of corrections and removals. By
facilitating the agency's orderly processing of reports, a uniform
numbering system will ensure the agency's prompt and efficient
attention to the information submitted. Moreover,
[[Page 27189]]
as discussed above in response to comment 26, the agency has published
a rule that will permit electronic submissions of some reports. A
uniform numbering system will greatly simplify the storage and
retrieval of electronic reports.
31. One comment stated that the current practice is for
manufacturers or distributors reporting a recall action to report to
the FDA district office in the area where the manufacturer's or
distributor's site conducting the recall is located. The comment stated
that a report of correction or removal should be submitted to the FDA
district office with jurisdiction over the location of the manufacturer
that is conducting the correction/removal action. Some comments stated
that the reports of corrections and removals should be submitted to the
FDA district office in which the facility coordinating the correction
or removal is located. Other comments stated that reports should be
made to FDA headquarters rather than to each district office.
FDA believes that reports of corrections and removals should be
sent to the district office for the district in which the reporting
facility is located, whether it is the distributor's site,
manufacturing site, or the corporate office. The district office in the
reporting facility's district will have direct contact with the
reporting firm, as it does now with recalling firms, and will therefore
be able to monitor the firm's actions more easily, and in a timely
fashion. Manufacturers, distributors, and importers are expected to
follow company policy for submission of reports of actions involving
multiple operations. For foreign firms, reports should be made to the
district office of the district in which any initial distributor of the
device in the United States is located.
32. One comment stated that the March 1994 proposed rule will
impose significant costs on manufacturers and distributors of medical
devices. Some comments stated that the projection of no more than 800
reports per year grossly underestimates the likely number. Other
comments stated that the cost is underestimated.
FDA has revised aspects of the final rule, in particular the
definition of ``risk to health,'' as discussed above. FDA believes that
these revisions substantially narrow the definition of reportable
events. Based on the number of voluntary recalls reported to FDA since
1990 and the number of unreported recalls identified through FDA's
investigations, the estimate provided in the March 1994 proposed rule
for 800 reports should be adjusted slightly upward to 880. The agency
typically uncovers 40 unreported events annually. FDA's estimates are
discussed in more detail in sections IV and V of this document. FDA
believes that the information it has used to project the number of
reports is reliable and that 800 to 880 reports is a rational, well-
justified estimate of the number of reports the agency will receive.
33. Some comments expressed concern over confidentiality of the
reports of corrections and removals submitted to FDA. For the most
part, comments recommended that FDA delete the names, addressees, and
telephone numbers of consignees prior to public disclosure of reports
of corrections and removals.
FDA is aware of confidentiality concerns. For the most part, FDA is
required under the Freedom of Information Act (FOIA) (5 U.S.C. 552), to
make reports of corrections and removals publicly available. The public
availability of such reports is governed by the FOIA and part 20 (21
CFR part 20). Before a report is made publicly available in accordance
with the FOIA and part 20, FDA will delete from the report information
whose disclosure would constitute an invasion of personal privacy (see
5 U.S.C. 552(b)(6); Sec. 20.63), or information that constitutes trade
secret or confidential commercial or financial information (see 5
U.S.C. 552(b)(4); Sec. 20.61). The public availability of the reports
required by this regulation is discussed in Sec. 806.40.
II. Enforcement
Violations of this rule, which is issued under the authority of
sections 502, 510, 519, 520, 701, and 704 of the act (21 U.S.C.
sections 352, 360, 360i, 360j, 371, and 374), will result in committing
one or more of the following violations of section 301 of the act:
1. Section 301(e) of the act (21 U.S.C. 331(e)), which prohibits,
among other things, the failure to establish or maintain any record, or
make any report, required under section 519 of the act or the refusal
to permit officers or employees designated by FDA to have access to or
verification or copying of any such required record.
2. Section 301(f) of the act, which prohibits the refusal to permit
entry or inspection as authorized by section 704 of the act (21 U.S.C.
374). Section 704(e) of the act requires every person required under
section 519 of the act to maintain records and every person who is in
charge or custody of such records, upon request of an officer or
employee designated by FDA, to permit such officer or employee to have
access to, and copy and verify, such records.
3. Section 301(q) of the act, which prohibits, among other things,
the failure or refusal to furnish any material or information required
by or under section 519 of the act or the submission of such a report
that is false or misleading in any respect.
In addition, section 502(t)(2) of the act deems a device to be
misbranded if there was a failure or refusal to furnish any material or
information required by or under section 519 of the act respecting the
device. Section 301(a), (b), (c), (g), and (k) of the act prohibit
several actions with respect to misbranded devices. Persons who violate
section 301 of the act may be restrained, under section 302 of the act
(21 U.S.C. 332), or may be imprisoned or fined under section 303 of the
act (21 U.S.C. 333). FDA may also seize misbranded devices under
section 304 of the act (21 U.S.C. 334).
The SMDA also added section 303(f) to the act, which provides for
the first time that any person who fails to demonstrate substantial
compliance with section 519(f) of the act may be subject to civil
penalties. These penalties do not apply to any person who commits minor
violations of section 519(f) of the act with respect to correction
reports, if such person demonstrates substantial compliance with
section 519(f). A civil penalty may not exceed $15,000 for a single
violation, and may not exceed $1,000,000 for all such violations
adjudicated in a single proceeding.
III. Environmental Impact
The agency has determined that this action falls within the
category of actions described in 21 CFR 25.24(a)(8) which do not
individually or cumulatively have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives, and when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity. The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. If a rule has a
significant
[[Page 27190]]
economic impact on a substantial number of small entities, the
Regulatory Flexibility Act requires agencies to analyze regulatory
options that would minimize any significant impact of the rule on small
entities.
The final rule requires medical device manufacturers, importers,
and distributors to report promptly to FDA any correction or removal of
a device undertaken to reduce a risk to health posed by the device or
to remedy a violation of the act that could present a risk to health
caused by the device. FDA currently receives, as voluntary reports
under part 7, an estimated 800 reports of corrections and removals each
year and typically uncovers an additional 40 unreported events.
Factoring in an additional 40 reports that FDA does not uncover, FDA
estimates that it will receive about 880 reports of corrections and
removals under Sec. 806.10 annually and that entities will be required
to keep records of an additional 440 events. There are more than 20,000
manufacturers, importers, and distributors of medical devices subject
to this rule. The large majority of entities will not be required to
submit any reports in any particular year, and, most likely, only the
largest entities would be required to report more than 1 or 2 events in
any year. Because of the relatively small incremental increase in
reporting and recordkeeping required by this rule and the relatively
modest costs attendant upon that increase, the Commissioner of Food and
Drugs certifies that the final rule will not have a significant
economic impact on a substantial number of small entities. The factual
basis for this certification is the estimate that the implementation of
the corrections and removals provision will require approximately 880
reports per year and recordkeeping of approximately 440 events.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required. FDA has sent its certification and the factual basis for it
set out above to the Chief Counsel for Advocacy, Small Business
Administration.
V. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
provisions are shown below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Reports of Corrections and Removals for Manufacturers,
Importers, and Distributors of Medical Devices.
Description: This regulation establishes the procedures for
implementing the reports of corrections and removals provisions of the
SMDA. The purpose of this regulation is to protect the public health by
permitting FDA to promptly receive information about devices that have
been corrected or removed to avert a risk to health or to remedy a
violation of the act that could present a risk to health. The
collection of this information is required by section 519(f) of the
act.
Description of Respondents: Businesses or other for profit
organizations.
Table 1.--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
806.10 880 1 880 10 8,800
----------------------------------------------------------------------------------------------------------------
Table 2.--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
806.20 440 1 440 10 4,400
----------------------------------------------------------------------------------------------------------------
There are no capital or operating and maintenance costs expected as a result of this final rule.
Although the March 1994 proposed rule provided a 90-day comment
period under the Paperwork Reduction Act of 1980, and this final rule
is based on comments received, the proposed rule has not been
previously available to OMB for review. FDA invites comments on: (1)
Whether the proposed collection of information is necessary for the
proper performance of FDA's functions, including whether the
information will have practical utility; (2) the accuracy of FDA's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through use of automated
collection techniques, when appropriate, and other forms of information
technology.
Although the reporting burden estimate in the March 1994 proposed
rule was 8,000 hours, based on an evaluation of the agency's recent
experience with the voluntary recall rule and the MDR rule, FDA now
estimates that the annual reporting burden for respondents in
Sec. 806.10 is 8,800 hours. The adjusted total estimated annual
recordkeeping burden is now 4,400 hours (Table 1).
Individuals and organizations desiring to submit comments regarding
FDA's burden estimates or any aspects of the information collection
provisions of the final rule should do so by July 18, 1997. These
comments should be directed to FDA's Dockets Management Branch (address
above).
At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a notice in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of this final rule, FDA will publish a notice in the
Federal Register of OMB's
[[Page 27191]]
decision to approve, modify, or disapprove the information collection
provisions. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
List of Subjects in 21 CFR Part 806
Corrections and removals, Medical devices, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
806 is added to read as follows:
PART 806--MEDICAL DEVICE CORRECTIONS AND REMOVALS
Subpart A--General Provisions
Sec.
806.1 Scope.
806.2 Definitions.
Subpart B--Reports and Records
806.10 Reports of corrections and removals.
806.20 Records of corrections and removals not required to be
reported.
806.30 FDA access to records.
806.40 Public availability of reports.
Authority: Secs. 502, 510, 519, 520, 701, and 704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371,
374).
Subpart A--General Provisions
Sec. 806.1 Scope.
(a) This part implements the provisions of section 519(f) of the
Federal Food, Drug, and Cosmetic Act (the act) requiring device
manufacturers and distributors, including importers, to report promptly
to the Food and Drug Administration (FDA) certain actions concerning
device corrections and removals, and to maintain records of all
corrections and removals regardless of whether such corrections and
removals are required to be reported to FDA.
(b) The following actions are exempt from the reporting
requirements of this part:
(1) Actions undertaken by device manufacturers and distributors,
including importers, to improve the performance or quality of a device
but that do not reduce a risk to health posed by the device or remedy a
violation of the act caused by the device.
(2) Market withdrawals as defined in Sec. 806.2(h).
(3) Routine servicing as defined in Sec. 806.2(k).
(4) Stock recoveries as defined in Sec. 806.2(l).
Sec. 806.2 Definitions.
As used in this part:
(a) ``Act'' means the Federal Food, Drug, and Cosmetic Act.
(b) ``Agency'' or ``FDA'' means the Food and Drug Administration.
(c) ``Consignee'' means any person or firm that has received,
purchased, or used a device subject to correction or removal.
(d) ``Correction'' means the repair, modification, adjustment,
relabeling, destruction, or inspection (including patient monitoring)
of a device without its physical removal from its point of use to some
other location.
(e) ``Correction or removal report number'' means the number that
uniquely identifies each report submitted.
(f) ``Distributor'' means any person, including any person who
imports a device into the United States, who furthers the marketing of
a device from the original place of manufacture to the person who makes
final delivery or sale to the ultimate user, but who does not repackage
or otherwise change the container, wrapper, or labeling of the device
or device package.
(g) ``Manufacturer'' means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device by chemical,
physical, biological, or other procedures. The term includes any person
who:
(1) Repackages or otherwise changes the container, wrapper, or
labeling of a device in furtherance of the distribution of the device
from the original place of manufacture to the person who makes final
delivery or sale to the ultimate user or consumer;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications; or
(3) Manufactures components or accessories which are devices that
are ready to be used and are intended to be commercially distributed
and are intended to be used as is, or are processed by a licensed
practitioner or other qualified person to meet the needs of a
particular patient.
(h) ``Market withdrawal'' means a correction or removal of a
distributed device that involves a minor violation of the act that
would not be subject to legal action by FDA or that involves no
violation of the act, e.g., normal stock rotation practices.
(i) ``Removal'' means the physical removal of a device from its
point of use to some other location for repair, modification,
adjustment, relabeling, destruction, or inspection.
(j) ``Risk to health'' means
(1) A reasonable probability that use of, or exposure to, the
product will cause serious adverse health consequences or death; or
(2) That use of, or exposure to, the product may cause temporary or
medically reversible adverse health consequences, or an outcome where
the probability of serious adverse health consequences is remote.
(k) ``Routine servicing'' means any regularly scheduled maintenance
of a device, including the replacement of parts at the end of their
normal life expectancy, e.g., calibration, replacement of batteries,
and responses to normal wear and tear. Repairs of an unexpected nature,
replacement of parts earlier than their normal life expectancy, or
identical repairs or replacements of multiple units of a device are not
routine servicing.
(l) ``Stock recovery'' means the correction or removal of a device
that has not been marketed or that has not left the direct control of
the manufacturer, i.e., the device is located on the premises owned, or
under the control of, the manufacturer, and no portion of the lot,
model, code, or other relevant unit involved in the corrective or
removal action has been released for sale or use.
Subpart B--Reports and Records
Sec. 806.10 Reports of corrections and removals.
(a) Each device manufacturer, importer, or distributor shall submit
a written report to FDA of any correction or removal of a device
initiated by such manufacturer or distributor if the correction or
removal was initiated:
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may
present a risk to health unless the information has already been
provided as set forth in paragraph (f) of this section or the
corrective or removal action is exempt from the reporting requirements
under Sec. 806.1(b).
(b) The manufacturer, importer, or distributor shall submit any
report required by paragraph (a) of this section within 10-working days
of initiating such correction or removal. The report shall be submitted
to the appropriate FDA district office listed in Sec. 5.115 of this
chapter. A foreign manufacturer or owner or operator of devices must
submit reports of corrective or removal actions.
(c) The manufacturer, importer, or distributor shall include the
following information in the report:
(1) The seven digit registration number of the entity responsible
for
[[Page 27192]]
submission of the report of corrective or removal action (if
applicable), the month, day, and year that the report is made, and a
sequence number (i.e., 001 for the first report, 002 for the second
report, 003 etc.), and the report type designation ``C'' or ``R''. For
example, the complete number for the first correction report submitted
on June 1, 1997, will appear as follows for a firm with the
registration number 1234567: 1234567-6/1/97-001-C. The second
correction report number submitted by the same firm on July 1, 1997,
would be 1234567-7/1/97-002-C etc. For removals, the number will appear
as follows: 1234567-6/1/97-001-R and 1234567-7/1/97-002-R, etc. Firms
that do not have a seven digit registration number may use seven zeros
followed by the month, date, year, and sequence number (i.e. 0000000-6/
1/97-001-C for corrections and 0000000-7/1/97-001-R for removals).
Reports received without a seven digit registration number will be
assigned a seven digit central file number by the district office
reviewing the reports.
(2) The name, address, and telephone number of the manufacturer,
importer, or distributor and the name, title, address, and telephone
number of the manufacturer, importer, or distributor's representative
responsible for conducting the device correction or removal.
(3) The brand name and the common name, classification name, or
usual name of the device and the intended use of the device.
(4) Marketing status of the device, i.e., any applicable premarket
notification number, premarket approval number, or indication that the
device is a preamendments device, and the device listing number. A
manufacturer, importer, or distributor that does not have an FDA
establishment registration number shall indicate in the report whether
it has ever registered with FDA.
(5) The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other
identification number.
(6) The manufacturer's name, address, telephone number, and contact
person if different from that of the person submitting the report.
(7) A description of the event(s) giving rise to the information
reported and the corrective or removal actions that have been, and are
expected to be taken.
(8) Any illness or injuries that have occurred with use of the
device. If applicable, include the medical device report numbers.
(9) The total number of devices manufactured or distributed subject
to the correction or removal and the number in the same batch, lot, or
equivalent unit of production subject to the correction or removal.
(10) The date of manufacture or distribution and the device's
expiration date or expected life.
(11) The names, addresses, and telephone numbers of all domestic
and foreign consignees of the device and the dates and number of
devices distributed to each such consignee.
(12) A copy of all communications regarding the correction or
removal and the names and addresses of all recipients of the
communications not provided in accordance with paragraph (c)(11) of
this section.
(13) If any required information is not immediately available, a
statement as to why it is not available and when it will be submitted.
(d) If, after submitting a report under this part, a manufacturer,
distributor, or importer determines that the same correction or removal
should be extended to additional lots or batches of the same device,
the manufacturer, distributor, or importer shall within 10-working days
of initiating the extension of the correction or removal, amend the
report by submitting an amendment citing the original report number
assigned according to paragraph (c)(1) of this section, all of the
information required by paragraph (c)(2), and any information required
by paragraphs (c)(3) through (c)(12) of this section that is different
from the information submitted in the original report. The
manufacturer, distributor, or importer shall also provide a statement
in accordance with paragraph (c)(13) of this section for any required
information that is not readily available.
(e) A report submitted by a manufacturer, distributor, or importer
under this section (and any release by FDA of that report or
information) does not necessarily reflect a conclusion by the
manufacturer, distributor, importer, or FDA that the report or
information constitutes an admission that the device caused or
contributed to a death or serious injury. A manufacturer, distributor,
or importer need not admit, and may deny, that the report or
information submitted under this section constitutes an admission that
the device caused or contributed to a death or serious injury.
(f) No report of a correction or removal is required under this
part, if a report of the correction or removal is required and has been
submitted under parts 803, 804, or 1004 of this chapter.
Sec. 806.20 Records of corrections and removals not required to be
reported.
(a) Each device manufacturer, importer, or distributor who
initiates a correction or removal of a device that is not required to
be reported to FDA under Sec. 806.10 shall keep a record of such
correction or removal.
(b) Records of corrections and removals not required to be reported
to FDA under Sec. 806.10 shall contain the following information:
(1) The brand name, common or usual name, classification, name and
product code if known, and the intended use of the device.
(2) The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other
identification number.
(3) A description of the event(s) giving rise to the information
reported and the corrective or removal action that has been, and is
expected to be taken.
(4) Justification for not reporting the correction or removal
action to FDA, which shall contain conclusions and any followups, and
be reviewed and evaluated by a designated person.
(5) A copy of all communications regarding the correction or
removal.
(c) The manufacturer, importer, or distributor shall retain all
records required under this section for a period of 2 years beyond the
expected life of the device, even if the manufacturer, importer, or
distributor has ceased to manufacture, import, or distribute the
device. Records required to be maintained under paragraph (b) of this
section must be transferred to the new manufacturer, importer, or
distributor of the device and maintained for the required period of
time.
Sec. 806.30 FDA access to records.
Each device manufacturer, importer, or distributor required under
this part to maintain records concerning corrections or removals and
every person who is in charge or custody of such records shall, upon
request of an officer or employee designated by FDA and under section
704(e) of the act, permit such officer or employee at all reasonable
times to have access to, and to copy and verify, such records and
reports.
Sec. 806.40 Public availability of reports.
(a) Any report submitted under this part is available for public
disclosure in accordance with part 20 of this chapter.
(b) Before public disclosure of a report, FDA will delete from the
report:
(1) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61 of this chapter;
and
[[Page 27193]]
(2) Any personnel, medical, or similar information, including the
serial numbers of implanted devices, which would constitute a clearly
unwarranted invasion of personal privacy under Sec. 20.63 of this
chapter or 5 U.S.C. 552(b)(6); provided, that except for the
information under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA
will disclose to a patient who requests a report all the information in
the report concerning that patient.
Dated: May 9, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-13064 Filed 5-16-97; 8:45 am]
BILLING CODE 4160-01-F
