[Federal Register Volume 59, Number 239 (Wednesday, December 14, 1994)]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30422]
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[Federal Register: December 14, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 807
[Docket No. 91N-0388]
Medical Devices; Substantial Equivalence; 510(K) Summaries and
510(K) Statements; Class III Summaries; Confidentiality of Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this final
rule to implement the provisions of the Safe Medical Devices Act of
1990 (the SMDA) that require all persons who submit a premarket
notification (510(k)) to provide to FDA, as part of the submission, an
adequate summary (510(k) summary) of any information respecting safety
and effectiveness or a statement (510(k) statement) that such
information will be made available upon request by any person. This
rule also implements the requirement of the SMDA that 510(k) submitters
claiming substantial equivalence to a class III preamendments device
for which FDA has not yet called for premarket approval submit a class
III summary and certify that they have conducted a search of safety and
effectiveness data. In addition, this rule amends the device
regulations governing the confidentiality of certain premarket
notification submissions to conform to the SMDA. This rule also
provides that persons who submit a premarket notification must certify
that, to the best of their knowledge, all information is truthful and
accurate and that no material fact has been omitted.
EFFECTIVE DATE: March 14, 1995.
FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 28, 1992 (57 FR 18062), FDA issued
an interim rule implementing the provisions of the SMDA that require
persons who submit premarket notifications under section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) to
include an adequate summary of any information on safety and
effectiveness (510(k) summary) or a statement (510(k) statement) that
such information will be made available upon request by any person. The
interim rule also implemented the requirement that 510(k) submitters
claiming substantial equivalence to a class III preamendments device
for which FDA has not yet called for premarket approval certify (class
III certification) that they have conducted a search of safety and
effectiveness data concerning the device and submit a summary of, and a
citation to, all adverse safety and effectiveness information
respecting the device (class III summary). In addition, the interim
rule amended the device regulations governing the confidentiality of
certain premarket notification submissions to conform to the SMDA. The
interim rule also provided that persons who submit a premarket
notification must certify that the data and information are truthful
and accurate and that no material fact has been omitted. FDA stated
that the interim rule would become effective on May 28, 1992.
Interested persons were given until June 29, 1992, to comment on
the interim rule. In the Federal Register of June 1, 1992 (57 FR
23059), this comment period was extended until August 27, 1992, in
response to a petition filed by a trade association. The effective date
was stayed by FDA until the comments were reviewed and a new rule was
published and made effective.
II. Comments
The agency received 19 comments from trade associations,
manufacturers, a supplier, and a medical device consultant. A summary
of the comments and the agency's response to them is provided below:
1. One comment from a manufacturer questioned why Sec. 807.87(i)(2)
(21 CFR 807.87(i)(2)) of the interim rule stated that information that
already has been submitted to FDA under section 519 of the act (21
U.S.C. 360i) is not the type of information that would be included in a
class III summary. Section 519(a) of the act (21 U.S.C. 360i(a))
authorizes FDA to issue regulations requiring the manufacturers of
devices to maintain and provide records to ensure that devices are not
adulterated, misbranded, unsafe, or ineffective.
The SMDA (513(f)(3)) of the act (21 U.S.C. 360c(f)(3)) specifically
excludes all adverse safety and effectiveness data that have been
submitted to FDA under section 519 of the act from class III summaries
(summaries submitted by manufacturers claiming substantial equivalence
to a class III preamendments device for which FDA has not yet called
for a PMA). Although the statute does not require manufacturers to
submit such data more than once, the agency understands that a class
III summary may include information that has previously been submitted
under section 519 of the act.
2. Many comments argued that the certification requirement in
Sec. 807.87(j) of the interim rule should be deleted because FDA can
utilize existing programs and statutes to ensure that erroneous
information is not submitted to the agency. One comment further argued
that FDA cannot require the regulated community to certify the
completeness of any 510(k) submission because that completeness is
subject to a variety of interpretations.
As noted in the preamble to the interim rule, this certification
requirement was added in response to a July 1990 report by the Office
of the Inspector General (OIG) on internal controls covering the 510(k)
review process. In that report, the OIG stated that, ``because the
generic drug approval scandal has raised concern about industry's
behavior under the so-called `honor system,' we believe that the 510(k)
process needs a program to help ensure that what industry reports on
paper is in fact accurate.'' The OIG recommended requiring industry to
certify the accuracy of data submitted in 510(k) submission documents
in order to enhance the integrity of the 510(k) premarket notification
process. (See page 22 of OIG report). The agency believes that such a
requirement provides additional assurance that the data submitted are
complete and accurate. However, in response to the comment that
concerned the inability of any individual to know if information is
complete, FDA has modified the language in Sec. 807.87(j) to include
the phrase ``to the best of his or her knowledge.'' This certification
should be made by an industry representative, preferably the official
correspondent of the firm.
3. Several comments complained that FDA improperly expanded the
scope of the information required by the SMDA for summaries ``of any
information respecting safety and effectiveness'' by requiring such
summaries to contain ``data and information supporting a finding of
substantial equivalence, including all adverse safety and effectiveness
information.'' A few comments noted that FDA's decision to treat all
information submitted in support of a substantial equivalence
determination as ``safety and effectiveness'' information seems
contrary to the notion that ``substantial equivalence'' determinations
are, on their face, determinations of ``equivalence,'' and not of
safety and effectiveness. One comment cited an FDA publication on
510(k) requirements, which stated, ``The purpose of data, such as
clinical data, for a premarket notification submission is to
demonstrate that the device is equivalent in performance to the
preamendments device. FDA does not intend that the data determine the
device's safety and effectiveness.'' See ``Premarket Notification:
510(k) Regulatory Requirements for Medical Devices,'' HHS Publication
FDA 90-4158, August 1990, p. 2. Another comment stated that information
concerning device design, intended use, or technological
characteristics is useful information which may support a determination
of substantial equivalence, but may not support a determination of
safety and effectiveness.
FDA believes that Congress clearly intended the concept of
``substantial equivalence'' to include some inquiry into the safety and
effectiveness of a new device, and that such inquiries into safety and
effectiveness are often inseparable from other bases of determining
substantial equivalence. The Report by the Committee on Interstate and
Foreign Commerce on the Medical Device Amendments of 1976 (House
Report) indicates that ``substantial equivalence'' is to be assessed
not only in relation to physical characteristics and intended use, but
sometimes also in terms of safety and effectiveness. The committee
believed that the term ``substantially equivalent'' ``should be
construed narrowly where necessary to assure the safety and
effectiveness of a device but not so narrowly where differences between
a new device and a marketed device do not relate to safety and
effectiveness.'' (H. Rept. No. 94-853, p. 36.)
The 1976 amendments, therefore, provided FDA with statutory
authority to consider the safety and effectiveness of a device when
determining whether such a device is substantially equivalent to a
predicate device. The legislative history of the 1990 amendments states
Congress' express intent to codify FDA's interpretation of the term
``substantial equivalence,'' including the agency's determination that
substantial equivalence requires a finding of comparable safety and
effectiveness (S. Rept. 513, 101st Cong., 2d sess. 41 (1990)).
Accordingly, Sec. 807.3 (21 CFR 807.3), which defines a 510(k) summary
to be ``a summary * * * of the safety and effectiveness information
contained in a premarket notification submission upon which a
determination of substantial equivalence can be based'' merely codifies
the agency's long-standing interpretation, approved by Congress, that
safety and effectiveness can be an integral part of a substantial
equivalence determination. The agency has concluded, therefore, that
the requirement that summaries of safety and effectiveness data include
information supporting a finding of substantial equivalence is
consistent with legislative intent and agency practice.
4. One comment stated that FDA should revise the language on page
18062 of the interim rule which reads, ``FDA's decision regarding the
existence of substantial equivalence will be based on all the
information contained in the 510(k), not only the information contained
in the summary,'' to read as follows: ``FDA's decision regarding the
existence of substantial equivalence will be based on all the
information contained in a 510(k).'' This comment believed that the
510(k) summary is intended to be a synopsis of safety and effectiveness
information for requestors, and is not intended for the use of FDA
reviewers when arriving at determinations of substantial equivalence.
Therefore, this comment suggested that the phrase ``510(k) safety and
effectiveness summary'' be inserted in lieu of the term ``510(k)
summary'' throughout the rule.
FDA agrees in part with this comment. As stated in the interim
rule, FDA's decision regarding the existence of substantial equivalence
will be based on all the information contained in the 510(k), not only
the information contained in the summary. However, the agency does not
agree that a change in terminology would significantly increase the
clarity of the rule and does not believe that the term ``510(k)
summary'' needs to be replaced with ``510(k) safety and effectiveness
summary'' throughout the rule.
5. One comment stated that the portion of the 510(k) summary
required in Sec. 807.92(a)(5) (21 CFR 807.92(a)(5)), ``statement of
intended use,'' should include definitions of the differences between
the submitter's new device and the legally marketed device, if the
indication statements are not the same. This comment further stated
that the brief discussion of nonclinical tests required as part of the
510(k) summary under Sec. 807.92(b)(1) should include references. The
comment further stated that the requirement should state clearly that
conclusions drawn from test results should compare the device with
legally marketed devices (Sec. 807.92(a)(3)).
The agency agrees in part with this comment. FDA believes that the
interim rule required sufficient detail about the intended use of the
device and its predicate. However, the agency has revised
Sec. 807.92(a)(5) on intended use to clarify that substantial
equivalence claims can only be made to predicates that are legally
marketed. With respect to the comment that conclusions from test
results should compare the device with legally marketed devices,
Sec. 807.92(b)(3) does require ``conclusions drawn from the nonclinical
and clinical tests that demonstrate that the device is as safe, as
effective, and performs as well as or better than the legally marketed
device * * *.'' Therefore, no revision of this provision is warranted.
6. One comment recommended that 510(k) summaries need include only
information required by Sec. 807.92(b)(3), which concerns conclusions
drawn from nonclinical and clinical tests that demonstrate comparable
safety, effectiveness, and performance of a new device to a legally
marketed device, as intended by Congress. Another comment also
recommended reducing the amount of information required in a 510(k)
summary, noting that information of a descriptive nature is sufficient
in most cases to allow a determination of substantial equivalence. This
comment argued that requiring 510(k) summaries to include clinical and
preclinical data in cases where such data are not necessary, would
require needless and costly data preparation and FDA review.
The agency has always required 510(k) submissions to include
descriptive data that are necessary to understand the indication,
physical composition, method of operation, specifications, or
performance claims of the device. Also, the agency has always required
any descriptive data about the legally marketed device that are
necessary to understand the characteristics of the device to which the
new device is being compared. A legally marketed device to which a new
device may be compared is a predicate device (device legally marketed
prior to May 28, 1976, or a device which has been classified from class
III to class II or class I), or a device which has been found to be
substantially equivalent through the 510(k) premarket notification
process. In order to clarify the definition of a legally marketed
device to which a new device may be compared for a determination
regarding substantial equivalence, the agency is amending
Sec. 807.92(a)(3) to include this definition of a legally marketed
device.
The new requirement for 510(k) summaries does not change or add to
the type of information that must be included in a 510(k) submission.
However, FDA has modified the language of Sec. 807.92(a)(4) to clarify
that descriptive information required for a 510(k) summary is expected
to be a condensed and summarized version of information in a 510(k)
submission, similar to labeling or promotional descriptions.
To date, the agency has required or used clinical investigation
data in less than 10 percent of its premarket notification submissions.
The agency generally requires clinical data when the description of a
new device indicates an important difference in comparison to marketed
devices within its type, i.e., new material or method of operation of
the new device. The agency may also require performance data when
descriptive characteristics of the new device are not sufficiently
precise to ensure that the new device, when manufactured according to
its description, will be comparable to the legally marketed device.
The legislative history of the SMDA explicitly supports FDA's
practice of requesting additional data in this regard in order to
determine substantial equivalence.
The determination of comparable safety and effectiveness is at
times easy, where the newer device and its predicate use the same
technologies. More difficult judgments occur when the technologies
of the devices differ. In this latter situation, FDA will not make a
substantial equivalence determination without data, including
clinical data, that demonstrates comparable safety and effectiveness
(S. Rept. 513, 101st Cong., 2d sess. 28 (1990)).
7. One comment suggested that the agency release the entire 510(k),
excluding trade secret and specific patient information, in lieu of
requiring safety and effectiveness summaries. In the alternative, this
comment suggested making the information required by Sec. 807.92(b)
part of the 510(k) cover letter supplied by the 510(k) submitter, and
then making the entire cover letter releasable because that letter
would ordinarily include the information requested in Sec. 807.92(a).
The agency disagrees. The release of either the entire 510(k),
excluding trade secret information and patient identifiers, or release
of the 510(k) cover letter, in lieu of the 510(k) submitter's 510(k)
summary would be inconsistent with the SMDA. Section 513(i) of the SMDA
expressly requires 510(k) submitters to submit summaries of information
that are intended for public disclosure respecting safety and
effectiveness or to state that such information will be made available
upon request by any person (21 U.S.C. 360c(i)(3)). There is no basis in
the legislation to require FDA to create summaries or substitutes for
summaries. However, if 510(k) submitters choose to have the entire
510(k), excluding patient identifiers and trade secret and confidential
commercial information, released in lieu of a 510(k) summary, they may
elect to submit a 510(k) statement and then release that information
themselves in response to requests from the public.
A. Trade Secret/Confidential Information
8. A few comments stated that FDA is precluded by the Freedom of
Information Act (the FOIA), 5 U.S.C. 552, and the act from divulging
trade secret information. Many comments believed that virtually all of
the technological information required by the interim rule to be made
public can qualify as trade secret information, even under the narrow
definition of ``trade secret'' adopted by the D.C. Court of Appeals in
Public Citizen Health Research Group v. Food and Drug Administration,
704 F.2d 1280, 1288 (D.C. Cir. 1983). Specifically, these comments
argued that the ``significant physical and performance characteristics
of the device such as device design, materials used, and physical
properties,'' constitute a commercially valuable plan, formula, or
process. Similarly, the chemical composition of various reagents and
controls, to the extent that nonactive ingredients are involved, would
also implicate the types of information that are normally closely
guarded as trade secrets by a 510(k) submitter.
The agency does not intend that submitters include trade secret or
confidential commercial information in the 510(k) summaries, which
Congress expressly intended for public disclosure. In addition, ``the
using by any person to his own advantage, or revealing, other than to *
* * the Department, or to the courts * * * any information acquired
under authority of section * * * 510 * * * concerning any method or
process which as a trade secret is entitled to protection'' is
prohibited under the act. (See section 301(j) of the act (21 U.S.C.
331(j))). The requirements set forth in Sec. 807.92(a)(4) and (a)(6)
have been modified to reflect the agency's intention that trade secret
and confidential commercial information be protected. For example, the
agency now states in Sec. 807.92(a)(4) that information concerning a
device's description may be information that a firm would disclose in
its device labeling or promotional material. The term ``statement'' in
Sec. 807.92(a)(6) has been replaced with ``summary'' to reflect the
agency's expectation that information provided concerning technological
characteristics will be provided in summary fashion, in a form that is
clear, concise, and adequate, but not so detailed as to disclose trade
secret information. As stated in the interim rule, if a premarket
notification submission contains only descriptive information to
support substantial equivalence, the 510(k) summary for that submission
would be required to contain only general information about the device
and a summary of the descriptive information that demonstrates the new
device is as safe and effective as the device to which the sponsor is
requesting substantial equivalence.
If a 510(k) submitter, however, fails to comply with the provisions
concerning 510(k) summaries or 510(k) statements, the agency may
provide the public with a purged copy of the 510(k) submission prepared
by agency staff. Under these circumstances, FDA would not follow
predisclosure notification procedures established for responses to FOIA
requests for 510(k) records.
9. One comment stated that because the interim rule transcends the
provisions of the FOIA, there must be an independent legal basis
authorizing disclosure of trade secret information prohibited from
release by the Trade Secrets Act (the TSA), 18 U.S.C. 1905. Citing
Chrysler Corp. v. Brown, 441 U.S. 281 (1979), this comment argued that
while ``properly promulgated, substantive agency regulations have the
`force and effect of law','' an interpretative regulation does not have
the force and effect of law necessary to obviate the restrictions in
the TSA. Id. at p. 295 and 302. Thus, for agency action to qualify as
``authorized by law,'' under TSA, ``* * * it must have certain
substantive characteristics and be the product of certain procedural
requisites.'' Id. at p. 301. This comment noted that, in the preamble
to the interim rule, FDA concluded that the regulation is not a
substantive rule. Therefore, this comment argued, the regulation cannot
qualify as a regulation authorized by law under the TSA. Furthermore,
the comment continued, even if the interim rule had been labeled a
substantive rule, it would still not have the ``force and effect'' of
law because it was signed by the Acting Deputy Commissioner for Policy
who lacks authority to unilaterally issue rules under either the TSA or
the FOIA.
The agency disagrees. FDA's statutory authority for requiring
disclosure of particular information in a 510(k) summary is section 513
of the act, in which Congress expressly required release to any person
of such summaries. Congress also specifically authorized the Secretary
of the Department of Health and Human Services (the Secretary) to
establish the content of those summaries. The agency, therefore,
believes that a regulation promulgated to implement that section may
provide proper authorization for disclosure.
However, whether or not the analysis set forth in the comment
submitted to the agency is correct, the objections raised by that
comment are now irrelevant. As explained above, FDA does not expect
510(k) summaries to include trade secret or confidential commercial
information. In addition, the agency is modifying its statement, in the
interim rule, that a dispute over the adequacy of information provided
by a 510(k) statement submitter should require the release to the
requestor of confidential commercial information that is also
considered safety and effectiveness information. The agency has
concluded that a dispute over the adequacy of information provided in
support of a 510(k) statement should not require automatic disclosure
by the submitter of information that is properly protected from public
release. However, if the agency determines that a submitter is
attempting to undermine the 510(k) statement process by providing
information to requestors that is untimely or inadequate, such actions
will be deemed a prohibited act under section 301(q)(2) and (p) of the
act, and the agency will use a variety of means, including its
enforcement tools, to end violations. For example, in response to valid
complaints from requestors, FDA may choose to make purged copies of the
510(k) publicly available. (See also section III. of this document).
10. One comment stated that FDA's apparent abandonment of any
effort toward confidentiality raises serious concerns about proprietary
interests, intellectual property protection, liability issues, and
market timing. Indeed, another comment argued that the disclosure of
trade secret or confidential information results in a taking without
just compensation.
As noted in paragraphs 8 and 9 of this document, FDA recognizes its
obligation to protect information that is exempt or prohibited from
public disclosure, and the agency does not expect 510(k) summaries to
include such information.
11. A few comments stated that the interim rule will compel small
manufacturers to seek costly patent protection and discourage
innovation. One comment noted that many small entrepreneurs believe
that the expense of seeking patent protection is not warranted if the
characteristics of an otherwise patentable invention cannot be easily
ascertained through reverse engineering. However, this comment
continued, the effect of the interim rule would compel these small,
start-up companies to seek expensive and unnecessary patent protection
to protect trade secrets.
This final rule clarifies FDA's position that trade secret and
confidential commercial information need not be included in a 510(k)
statement or 510(k) summary. The agency takes this opportunity,
however, to remind manufacturers and submitters of 510(k)'s that
details about manufacture, composition, specification, performance, and
testing that are included in labeling or promotional materials cannot
be considered confidential under any circumstances.
B. 510(k) Summaries and Predisclosure Notification
12. One comment disputed the notion that information contained in a
510(k) submission is exempt from predisclosure requirements set forth
in Executive Order 12600. This comment believed that this exemption
should apply only to the information contained in a 510(k) summary,
rather than to the information contained in the actual 510(k)
submission. This comment maintained that a submitter should be afforded
the opportunity to submit a 510(k) summary prior to disclosure of the
information contained in a 510(k) submission.
FDA agrees. The premarket notification submission ordinarily is
subject to predisclosure notification under Executive Order 12600.
However, 510(k) summaries are prepared by submitters who know that
these summaries are intended for public disclosure. In light of the
statute and the agency's implementing regulation, submitters can have
no reasonable expectation that such documents will be withheld.
Accordingly, it would be unnecessary and inappropriate to subject
510(k) summaries to predisclosure notification. It is the 510(k)
submitter's obligation to prepare either a 510(k) summary of any
information respecting safety and effectiveness or provide a 510(k)
statement that the 510(k) submitter will make such information
available upon request.
With respect to the decision about whether to submit a 510(k)
summary or 510(k) statement, FDA is correcting the statement in the
preamble to the interim rule that this decision by the 510(k) submitter
may not be changed once the 510(k) submission has been received by FDA.
Instead, FDA now clarifies that a 510(k) submitter who elects to submit
a 510(k) summary when the premarket notification submission is filed,
may, before a substantial equivalence determination is reached, submit
either a revised 510(k) summary or a 510(k) statement in lieu of the
510(k) summary. Likewise, a 510(k) submitter who elects to submit a
510(k) statement when the premarket notification submission is filed,
may, before the substantial equivalence determination is reached,
submit a 510(k) summary in lieu of the 510(k) statement.
C. 510(k) Statements
13. Several comments said that Sec. 807.93 (21 CFR 807.93) places a
manufacturer who submits a 510(k) statement at risk to provide all
information, including trade secret or confidential commercial
information that relates to safety and effectiveness. Indeed, FDA
specifically concluded that manufacturers could not withhold such
information (see 57 FR 18062 at 18064).
The interim rule specifically requested comments on this issue and,
as noted above, the agency has changed its earlier interpretation.
14. A few comments noted that there is no rational basis for FDA to
treat 510(k) statements differently than 510(k) summaries for
confidentiality purposes. These comments asserted that Congress
provided two distinct options for 510(k) submitters in the SMDA, the
510(k) summary or the 510(k) statement. However, if FDA continues with
its current interpretation, the 510(k) statement undoubtedly would fall
into disuse because 510(k) submitters would choose not to release their
trade secret or confidential commercial information. Another comment
stated that FDA should clearly state that the selection of a 510(k)
statement by the submitting firm should be equally acceptable to the
agency and should not adversely affect the review process of the
510(k).
FDA agrees with these comments. The SMDA was not intended to deter
the submission of a 510(k) statement. Indeed, it provided 510(k)
submitters with two alternatives. The disparate treatment of the 510(k)
statement and 510(k) summary for confidentiality purposes in the
interim rule was incorrect. However, while FDA can implement disclosure
of 510(k) summaries that have been filed with the agency, FDA does not
have similar control over disclosure of information promised by 510(k)
statements. As stated above, noncompliance with the commitment made in
a 510(k) statement will be deemed prohibited acts under section 301
(q)(2) and (p) of the act and FDA will use its enforcement powers to
obtain compliance.
15. One comment stated that the certification language in
Sec. 807.93 contradicts FDA's prior advice concerning 510(k)
statements. The comment noted FDA's previous statement that 510(k)
statements should be submitted instead of 510(k) summaries until FDA
determined the content of 510(k) summaries, and FDA's previous
statement that trade secret and confidential commercial information
contained in a 510(k) that was the subject of a 510(k) statement need
not be disclosed to the public. Another comment stated that fairness
required the agency to clarify that the 510(k) submitters who relied on
existing laws and regulations, and on previous FDA advice concerning
confidentiality prior to the effective date of any interim rule
changing such protections, are entitled to withhold trade secret and
confidential commercial information.
FDA believes the concerns raised by this comment have been
addressed above. As noted in response to previous comments, the agency
does not intend to require 510(k) submitters to make public disclosures
of true trade secret or confidential commercial information.
16. Several comments proposed changes to the wording for
certification of 510(k) statements under Sec. 807.93. One comment
suggested: ``I certify * * * will make available all information
included in this premarket notification on safety and effectiveness,
except trade secret and/or confidential information, that supports a
finding of substantial equivalence * * *.''
Other comments suggested revising Sec. 807.93 to read as follows:
I certify that (contact person for the premarket notification)
will make available all information included in this premarket
notification on safety and effectiveness as identified in
Sec. 807.92 of this rule that supports a finding of substantial
equivalence within thirty (30) days of request by any person. The
information I agree to make available does not include confidential
patient identifiers.
FDA has incorporated elements of all these comments into the final
rule. The agency has modified the certification requirement so that it
is consistent with FDA's regulations prohibiting the disclosure of
trade secret and confidential commercial information. The statement
also has been changed to clarify that the commitment to release
information only becomes effective after a device has been determined
to be substantially equivalent. The agency has also amended the
certification language in Sec. 807.93 to reflect FDA's expectation that
the official correspondent in the firm will prepare the certification
on behalf of the firm.
The certification now states:
I certify that, in my capacity as (the position held in company
by person required to submit the premarket notification, preferably
the official correspondent in the firm), of (company name), I will
make available all information included in this premarket
notification on safety and effectiveness within 30 days of request
by any person if the device described in the premarket notification
submission is determined to be substantially equivalent. The
information I agree to make available will be a duplicate of the
premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers,
and trade secret and confidential commercial information as defined
in 21 CFR 20.61.
17. The agency received comments that indicated uncertainty about
the scope of the obligation of a 510(k) statement submitter to respond
to requests for safety and effectiveness information that are made
after the ownership of the 510(k) has changed, the device is no longer
marketed, or the firm is no longer in business.
The legislative history of the SMDA is silent on this issue. The
agency has concluded that the firm submitting the 510(k) statement has
a continuing obligation to comply with the 510(k) statement commitment,
unless the firm relieves itself of this obligation by requiring the new
510(k) holder to submit a 510(k) statement in accordance with
Sec. 807.93 to the agency in the situation where there has been a
transfer of ownership of a 510(k). In those cases, the original 510(k)
holder should inform any requesters of the transfer of obligation that
accompanied the transfer of ownership. If a firm ceases to market the
device, but continues to do business, it must continue to comply with
requests for information. However, if the firm goes out of business and
there has been no transfer of ownership, the agency will, upon
sufficient written notification, relieve the firm of its obligation to
honor requests for safety and effectiveness information from the
premarket notification submission. Under these circumstances, FDA will
release the entire premarket notification submission excluding patient
identifiers and any information that remains trade secret or
confidential commercial information.
18. Another comment suggested that the regulation identify the
kinds of documents that the public may have access to when requesting
safety and effectiveness information from a 510(k) statement submitter.
This comment noted that this could be accomplished by codifying the
statement in the preamble, ``FDA believes that the information a
submitter is required to furnish should be taken only from the
information contained in the premarket notification submission.''
FDA believes that the concern raised by this comment has been
addressed by the change in the language of Sec. 807.93. That regulation
clearly restricts the obligation of a 510(k) submitter to provide only
information that is contained in the premarket notification. The
regulation requires 510(k) holders who submit statements to provide
requestors with a duplicate of their premarket notification submission,
including any adverse information, but excluding patient identifiers
and trade secret or confidential information. (See 21 CFR 807.93(c)).
FDA believes that the establishment of this procedure for 510(k)
statement submitters is in furtherance of the act. The regulation
ensures that disclosures will be uniform to all requesters, that
preparation of the information for disclosure need be done only one
time by the submitter, and that confidential commercial and trade
secret information remains protected. FDA notes that 510(k) submissions
for any device found to be substantially equivalent have been available
to the public under the FOIA since 1976.
19. One comment stated that FDA should permit a 510(k) statement to
appear without any certification language, using a format such as the
following: ``Information in this 510(k) respecting safety and
effectiveness will be made available upon request by any person.''
Another comment noted that section 513(i) of the statute does not
require this statement to be made in the form of a ``certification.''
Although the statute does not expressly require ``certification,''
FDA does not agree that certification language should be eliminated
from the 510(k) statement. The agency believes that certification
provides additional assurance that submitters will comply with their
statutory obligations.
D. Timeframes
20. A couple of comments argued that there is no basis for the
agency's choice of a 30-day time limit for 510(k) statement submitters
to respond to requests for safety and effectiveness information. One
comment requested that FDA revise this timeframe to 90 days. Other
comments noted that there is no indication that the agency has
considered the burden that such a timeframe imposes upon a submitter,
or whether the burden could be offset by charging requesters for the
review time, assembly time, duplication, and mailing of the
information.
FDA believes that the equal choice provided by the statute for
510(k) submitters to submit either 510(k) summaries or 510(k)
statements indicates the intent of Congress that information should be
available to requesters at the same time after a finding of substantial
equivalence, without regard to the 510(k) submitter's choice of 510(k)
summary or 510(k) statement.
The agency has determined that imposing a 30-day timeframe on
510(k) statement submitters is not unduly burdensome. The agency
expects that 510(k) submitters who elect to file 510(k) statements will
begin purging the 510(k) submission at the time they file their
premarket notification submission.
The agency recognizes that some firms that currently have a 510(k)
under review may not have purged copies of their 510(k) submissions
ready for disclosure. Section 519(a)(i) of the act states that FDA
shall not impose requirements unduly burdensome to a device
manufacturer, taking into account the cost of complying with such
requirements and the need for protection of the public health and the
implementation of the act. The agency is establishing an effective date
of 90 days for this final rule. The agency believes that this will give
510(k) statement submitters whose 510(k)'s are under review, sufficient
time to prepare this information. After the 90 days have elapsed, the
agency will expect companies to comply with requests for information
within 30 days of receiving such requests.
The agency believes that 510(k) submitters may not charge
requestors for compiling and disseminating the data because such
charges would be inconsistent with congressional intent. Charges to
requestors could discourage disclosure of information Congress has
determined should be made available to the public. In addition, it
would be difficult for the agency to determine or monitor reasonable
fees for disclosure by 510(k) submitters. If a 510(k) submitter decides
that the preparation and dissemination of this information is too
costly, the firm may elect to submit a 510(k) summary in lieu of a
510(k) statement. A 510(k) summary can be submitted to the agency in
lieu of a 510(k) statement at any time before the substantial
equivalence determination is made. In that case, costs associated with
release of information to requestors will be standardized and
implemented by FDA.
21. Another comment suggested that the timeframe for providing
requestors with safety and effectiveness data in support of a
substantial equivalence determination should be 30 business days,
rather than 30 calendar days, and that all requests should be addressed
in writing to the official correspondent of the company. This comment
also suggested that the agency include language in the regulation that
would prohibit disclosure of this information to a company's
competitors without a substantiating justification. The comment also
stated that the rationale for the request should be known to the
company, and that all costs associated with the request should be borne
by the requestor.
The agency has determined that 30 calendar days, rather than 30
business days, is an appropriate timeframe because it is FDA's
expectation that such information will be prepared at or near the time
of the premarket notification submission. (See FDA's response to
comment 26 of this document). FDA also disagrees with the suggestion
that the agency's regulation should limit access to the data. There is
no provision in the statute that requires requestors to provide a
rationale for making their request for safety and effectiveness
information, or precludes them from sharing this information with any
other person, including competitors. Indeed, under FDA's current
regulations, the contents of a 510(k) submission are available for
public disclosure after FDA makes a determination of substantial
equivalence, so long as patient identifiers, trade secret, and
confidential commercial information are deleted. Such disclosures under
the FOIA are made without regard to the purpose or identity of the
requestor.
The new regulation, therefore, is entirely consistent with current
agency disclosure practices and should be familiar to many companies
who have previously prepared 510(k) submissions for public disclosure.
The agency believes that these final regulations and FDA's other public
information regulations protect trade secret and confidential
commercial information from public disclosure by providing 510(k)
submitters the opportunity to delete proprietary information from their
records. Accordingly, competitors will not gain an unfair competitive
advantage when 510(k) statement submitters release the information they
have pledged to disclose.
FDA does agree that all requests for information should be made to
the official correspondent of the company or the person whose name
appears on the list of premarket notification submissions found
substantially equivalent. This list is available from the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. The agency believes that
directing the request to one person within the firm will expedite the
dissemination of this information. The agency has modified
Sec. 807.93(b) accordingly. The issue of payment by requestors of
information to 510(k) submitters who have made 510(k) statements has
been addressed previously in paragraph 21 of this document.
E. Class III Summaries and Certifications
22. Many comments argued that the statute only requires a ``class
III summary'' to include information about the predicate device
referenced in the 510(k), and not about the generic type of device.
Another comment noted that a search for and summary of adverse safety
and effectiveness data concerning a generic device type will yield
substantial information that is not relevant to the 510(k) device or to
its predicate device(s), because design and functional variations can
make comparisons within an entire device type meaningless. These
comments believed that FDA should limit the search and summary
requirements to the device that is the subject of the 510(k) and its
predicate device(s), as Congress intended.
FDA disagrees with this interpretation of the statute. Section
513(f)(3)(C) states that ``the manufacturer shall certify * * * that
the manufacturer has conducted a reasonable search of all information
known or otherwise available to the manufacturer respecting such other
device and has included * * * a summary of and a citation to all
adverse safety and effectiveness data respecting such other device * *
*.'' FDA's requirement to include information concerning the ``type of
device'' is consistent with the language in the statute which requires
that ``all'' adverse safety and effectiveness data be submitted.
Furthermore, determinations regarding substantial equivalence
frequently require FDA to compare the safety and effectiveness
information for a new 510(k) submission with the safety and
effectiveness information concerning another device that has been found
substantially equivalent through the 510(k) premarket notification
process. (See 21 U.S.C. 360(i)(1)(A)). If the agency limited the scope
of the class III summary only to information concerning the predicate
chosen by the submitter, firms might fail to become aware of relevant
safety and effectiveness problems associated with the type of the
device they wish to market, including devices that have been found
substantially equivalent. In addition, the agency might not obtain
other information relevant to determining substantial equivalence.
23. Many comments stated that Sec. 807.94 (21 CFR 807.94) requires
the manufacturer to certify not only that he has conducted a reasonable
search for adverse safety and effectiveness information, but also that
he has absolutely included all such information in the summary. These
comments pointed out that a manufacturer could never know with
certainty that the information is complete or accurate, and therefore
would become subject to new and personal criminal liability based on
factors beyond his knowledge or control.
In response to these concerns, the agency has modified Sec. 807.94
to clarify that the class III certification is being made by the
individual on behalf of the firm who submitted the 510(k) and that the
class III summary is complete and accurate ``to the best of (the
certifier's) knowledge.''
F. 21 CFR 807.95--Confidentiality of Information
24. Many comments stated that FDA should revise the confidentiality
section of the regulation to allow manufacturers to preserve the
confidentiality of their 510(k) submission until the company is ready
to begin marketing the device. These comments contended that this could
be accomplished by granting manufacturers a provisional determination
of substantial equivalence, leaving the final determination until the
manufacturer is ready to market the device. One comment noted that,
previously, a submitter provided certification and was able to maintain
the confidentiality of its intention to market a device until such time
as the device was actually ready to be commercialized. This comment
further stated that the public disclosure of information about new
devices as mandated by Congress is of potential importance only when a
device is in a position to be marketed--a date which may be later than
the 30 days after a determination of substantial equivalence has been
made.
Another comment noted that it is unlikely that a device
manufacturer would make an early submission for a premarket
notification if it knows that competitors might gain access to
confidential product and marketing information. As a result, the
premarket notification process would be lengthened because submitters
would wait to make such submissions in order to prevent others from
gaining a competitive edge. This comment asserted that even though the
SMDA requires FDA to make certain information available about a 510(k)
notification within 30 days of a substantial equivalence determination,
this does not mean that confidentiality under Sec. 807.95(c) cannot be
maintained.
FDA acknowledges that, in the past, manufacturers could request
that a 510(k) clearance remain confidential until the device was
actually marketed. However, the agency can no longer provide such
extended confidentiality because of the statutory requirement that
510(k) summaries be available to the public within 30 days of the
issuance of a determination that such device is substantially
equivalent to another device. Even if the alternative suggested were
more practical, the agency believes it lacks authority to extend this
timeframe to the date a 510(k) submitter expects to begin marketing.
G. Procedures
25. One comment suggested that FDA consider formalizing
administrative procedures by which companies submit premarket
notifications, by which FDA reviews original premarket notifications
and subsequent amendments thereto, and by which substantial equivalence
orders are issued. Another comment contended that the issuance of
formal administrative procedures would significantly ``balance the
playing field'' for FDA management, for FDA reviewers, and for
industry.
Administrative procedures are in place for submission, management,
and review of premarket notifications. (See part 807 (21 CFR part 807)
subpart E). FDA agrees that educational efforts concerning these
procedures should be continued. The agency has issued numerous
regulatory, guidance, and policy documents concerning premarket
notifications and will continue to issue similar documents. These
documents are available through the Center for Devices and Radiological
Health's Division of Small Manufacturers Assistance. In addition, it is
the agency's expectation that this final rule will further clarify the
requirements for premarket notification 510(k) summaries and 510(k)
statements.
26. One comment requested FDA to provide an amendment process for
510(k) summaries that would permit the submitter of a 510(k) summary to
amend it at any point in the review of the 510(k) prior to FDA's
determination of substantial equivalence.
FDA will accept amendments to 510(k) summaries until such time as
FDA makes a determination of substantial equivalence and has amended
Sec. 807.92(a) to state this policy. Additionally, firms that elect to
submit 510(k) statements at the time they file the premarket
notification may change their minds and submit a 510(k) summary before
the substantial equivalence determination is made. (See also response
to paragraph 13 of this document).
H. Miscellaneous
27. One comment from a manufacturer noted that, in the preamble to
the interim rule, a change in material would be considered a
significant difference for purposes of determining substantial
equivalence (see 57 FR 18062 at 18063). The comment stated that not all
changes in materials are ``significant.'' The comment further stated
that the interim rule provided no guidance or formal procedures that
would be applied to demonstrate equivalence or determine what
constitutes a significant change. The comment contended that existing
Sec. 807.87(g) appropriately addresses the issue of significant change.
FDA agrees that there are existing regulations that address the
definition of ``significant change.'' The agency believes that the
criteria for a ``significant change'' are set forth in
Sec. 807.81(a)(3) (21 CFR 807.81(a)(3)). In addition, examples of what
constitutes a significant change, as well as a detailed discussion of
FDA's decisionmaking process for 510(k) applications, is contained in
``FDA's Guidance on the Premarket Notification Review Program'' and
FDA's recent draft guidance, ``Deciding when to submit a 510(k) for a
change to an existing device.'' These publications are available from
the Division of Small Manufacturers Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 800-638-2041 or 301-443-6597.
The regulation that is the subject of this rulemaking is not
intended to supplant current regulations and guidelines concerning
significant change. The new regulation builds on existing regulations
and guidance in order to implement the section of the SMDA that directs
the Secretary to establish the requirements for 510(k) summaries under
section 513(i)(3)(B) of the act.
I. Effective Date
28. One comment stated that 60 days after date of publication is a
reasonable effective date for the interim rule. Other comments argued
that more time would be needed, particularly for companies who utilize
the 510(k) statement and need to be in a position to comply with the
30-day timeframe for responding to requestors.
The agency is establishing a 90-day effective date after date of
publication for all provisions in this rule, for the reasons discussed
in paragraph 20 of this document.
III. Enforcement
FDA emphasizes that it is the 510(k) submitter's responsibility to
prepare adequate 510(k) summaries, or to respond appropriately to
requests for information from the public when the submitter has chosen
to submit a 510(k) statement. If FDA determines that a submitter of a
510(k) summary or 510(k) statement has failed to comply properly with
these regulations, FDA may provide the public with a purged copy of the
510(k) submission prepared by agency staff. Under these circumstances,
FDA would not follow predisclosure notification procedures established
for responses to FOIA requests for 510(k) submissions. Failure to
comply with the requirements established by section 513(i) of the SMDA
is a prohibited act under section 301(q)(2) and (p) of the act, and the
agency will use its enforcement powers to deter noncompliance.
Violations under section 301 of the act may be subject to seizure or
injunction pursuant to sections 302(a) and 304(a) of the act (21 U.S.C.
332(a) and 334(a) respectively). In addition, a 510(k) submitter
responsible for violating section 301 of the act may be subject to
civil penalties under section 303(f) of the act (21 U.S.C. 333(f)) and
criminal prosecution under section 303(a) of the act (21 U.S.C.
333(a)).
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
An analysis of the costs and benefits of this regulation, conducted
under Executive Order 12291, was discussed in the interim rule and the
substance of that analysis has not changed. Executive Order 12291 has
been superseded by Executive Order 12866.
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
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 rule is consistent with the regulatory philosophy and principles
identified in the Executive Order. In addition, the rule is not a
significant regulatory action as defined by the Executive Order and so
is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The provisions of the final rule, including the
codification of the content requirements for 510(k) summaries, 510(k)
statements, class III summaries, and class III certifications should
assist submitters in organizing their submissions by giving submitters
a framework for organizing the discussion of substantial equivalence.
The regulation may be used as a checklist by submitters whenever they
submit a 510(k) summary, a 510(k) statement, a class III summary, or a
class III certification. This should result in better submissions and
more efficient review. The costs of the rule will be spread among
several thousand marketers in any year. For these reasons, the agency
certifies that the rule will not have a significant economic impact on
a substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
VI. Paperwork Reduction Act of 1980
Sections 807.87(h) and 807.87(i) of this final rule contain
reporting requirements that were submitted for review and approval to
the Director of the Office of Management and Budget (OMB), as required
by section 3504(h) of the Paperwork Reduction Act of 1980. The
requirements were approved and assigned OMB control number 0910-0281
and are in conformance with the Paperwork Reduction Act of 1980 (44
U.S.C. Ch. 35). The annual burden for reporting is as follows:
Annual Burden for Reporting
----------------------------------------------------------------------------------------------------------------
No. of
CFR section No. of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Summaries 807.87(h)............. 1,645 1 1,645 23 37,835
Statements 807.87(h)............ 3,055 1 3,055 .65 1,986
Citations 807.87(i)............. 500 1 500 42 21,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 60,821
----------------------------------------------------------------------------------------------------------------
List of Subjects in 21 CFR Part 807
Confidential business information, 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, the interim
rule amending 21 CFR part 807, which published in the Federal Register
of April 28, 1992 (57 FR 18062), and stayed at 57 FR 23059, is adopted
effective March 14, 1995 as a final rule with the following changes:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND DISTRIBUTORS OF DEVICES
1. The authority citation for 21 CFR part 807 continues to read as
follows:
Authority: Secs. 301, 501, 502, 510, 513, 515, 519, 520, 701,
704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351,
352, 360, 360c, 360e, 360i, 360j, 371, 374).
2. Section 807.3 is amended by revising the first sentence of
paragraph (n) and paragraphs (o) and (q) to read as follows:
Sec. 807.3 Definitions.
* * * * *
(n) 510(k) summary (summary of any information respecting safety
and effectiveness) means a summary, submitted under section 513(i) of
the act, of the safety and effectiveness information contained in a
premarket notification submission upon which a determination of
substantial equivalence can be based * * *.
(o) 510(k) statement means a statement, made under section 513(i)
of the act, asserting that all information in a premarket notification
submission regarding safety and effectiveness will be made available
within 30 days of request by any person if the device described in the
premarket notification submission is determined to be substantially
equivalent. The information to be made available will be a duplicate of
the premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers, and
trade secret or confidential commercial information, as defined in
Sec. 20.61 of this chapter.
* * * * *
(q) Class III summary means a summary of the types of safety and
effectiveness problems associated with the type of device being
compared and a citation to the information upon which the summary is
based. The summary must be comprehensive and describe the problems to
which the type of device is susceptible and the causes of such
problems.
3. Section 807.87 is amended by revising the first sentence of
paragraph (i)(2) and paragraph (j), and by adding a parenthetical
statement at the end of the section to read as follows:
Sec. 807.87 Information required in a premarket notification
submission.
* * * * *
(i) * * *
(2) For which no final regulation requiring premarket approval has
been issued under section 515(b) of the act, a summary of the types of
safety and effectiveness problems associated with the type of devices
being compared and a citation to the information upon which the summary
is based (class III summary). * * *
(j) A statement that the submitter believes, to the best of his or
her knowledge, that all data and information submitted in the premarket
notification are truthful and accurate and that no material fact has
been omitted.
* * * * *
(Information collection requirements in this section were approved
by the Office of Management and Budget (OMB) and assigned OMB
control number 0910-0281)
4. Section 807.92 is amended by revising the introductory text of
paragraph (a), paragraphs (a)(3), (a)(4), (a)(5), (a)(6), (b), and by
adding new paragraph (d) to read as follows:
Sec. 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an
understanding of the basis for a determination of substantial
equivalence. FDA will accept summaries as well as amendments thereto
until such time as FDA issues a determination of substantial
equivalence. All 510(k) summaries shall contain the following
information:
* * * * *
(3) An identification of the legally marketed device to which the
submitter claims equivalence. A legally marketed device to which a new
device may be compared for a determination regarding substantial
equivalence is a device that was legally marketed prior to May 28,
1976, or a device which has been reclassified from class III to class
II or I (the predicate), or a device which has been found to be
substantially equivalent through the 510(k) premarket notification
process;
(4) A description of the device that is the subject of the
premarket notification submission, such as might be found in the
labeling or promotional material for the device, including an
explanation of how the device functions, the scientific concepts that
form the basis for the device, and the significant physical and
performance characteristics of the device, such as device design,
material used, and physical properties;
(5) A statement of the intended use of the device that is the
subject of the premarket notification submission, including a general
description of the diseases or conditions that the device will
diagnose, treat, prevent, cure, or mitigate, including a description,
where appropriate, of the patient population for which the device is
intended. If the indication statements are different from those of the
legally marketed device identified in paragraph (a)(3) of this section,
the 510(k) summary shall contain an explanation as to why the
differences are not critical to the intended therapeutic, diagnostic,
prosthetic, or surgical use of the device, and why the differences do
not affect the safety and effectiveness of the device when used as
labeled; and
(6) If the device has the same technological characteristics (i.e.,
design, material, chemical composition, energy source) as the predicate
device identified in paragraph (a)(3) of this section, a summary of the
technological characteristics of the new device in comparison to those
of the predicate device. If the device has different technological
characteristics from the predicate device, a summary of how the
technological characteristics of the device compare to a legally
marketed device identified in paragraph (a)(3) of this section.
(b) 510(k) summaries for those premarket submissions in which a
determination of substantial equivalence is also based on an assessment
of performance data shall contain the following information:
(1) A brief discussion of the nonclinical tests submitted,
referenced, or relied on in the premarket notification submission for a
determination of substantial equivalence;
(2) A brief discussion of the clinical tests submitted, referenced,
or relied on in the premarket notification submission for a
determination of substantial equivalence. This discussion shall
include, where applicable, a description of the subjects upon whom the
device was tested, a discussion of the safety or effectiveness data
obtained from the testing, with specific reference to adverse effects
and complications, and any other information from the clinical testing
relevant to a determination of substantial equivalence; and
(3) The conclusions drawn from the nonclinical and clinical tests
that demonstrate that the device is as safe, as effective, and performs
as well as or better than the legally marketed device identified in
paragraph (a)(3) of this section.
* * * * *
(d) Any other information reasonably deemed necessary by the
agency.
5. Section 807.93 is revised to read as follows:
Sec. 807.93 Content and format of a 510(k) statement.
(a)(1) A 510(k) statement submitted as part of a premarket
notification shall state as follows:
I certify that, in my capacity as (the position held in company
by person required to submit the premarket notification, preferably
the official correspondent in the firm), of (company name), I will
make available all information included in this premarket
notification on safety and effectiveness within 30 days of request
by any person if the device described in the premarket notification
submission is determined to be substantially equivalent. The
information I agree to make available will be a duplicate of the
premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers,
and trade secret and confidential commercial information, as defined
in 21 CFR 20.61.
(2) The statement in paragraph (a)(1) of this section should be
signed by the certifier, made on a separate page of the premarket
notification submission, and clearly identified as ``510(k)
statement.''
(b) All requests for information included in paragraph (a) of this
section shall be made in writing to the certifier, whose name will be
published by FDA on the list of premarket notification submissions for
which substantial equivalence determinations have been made.
(c) The information provided to requestors will be a duplicate of
the premarket notification submission, including any adverse
information, but excluding all patient identifiers, and trade secret
and confidential commercial information as defined in Sec. 20.61 of
this chapter.
6. Section 807.94 is revised to read as follows:
Sec. 807.94 Format of a class III certification.
(a) A class III certification submitted as part of a premarket
notification shall state as follows:
I certify, in my capacity as (position held in company), of
(company name), that I have conducted a reasonable search of all
information known or otherwise available about the types and causes
of safety or effectiveness problems that have been reported for the
(type of device). I further certify that I am aware of the types of
problems to which the (type of device) is susceptible and that, to
the best of my knowledge, the following summary of the types and
causes of safety or effectiveness problems about the (type of
device) is complete and accurate.
(b) The statement in paragraph (a) of this section should be signed
by the certifier, clearly identified as ``class III certification,''
and included at the beginning of the section of the premarket
notification submission that sets forth the class III summary.
7. Section 807.95 is amended by revising paragraph (d) to read as
follows:
Sec. 807.95 Confidentiality of information.
* * * * *
(d) FDA will make a 510(k) summary of the safety and effectiveness
data available to the public within 30 days of the issuance of a
determination that the device is substantially equivalent to another
device. Accordingly, even when a 510(k) submitter has complied with the
conditions set forth in paragraphs (b) and (c) of this section,
confidentiality for a premarket notification submission cannot be
granted beyond 30 days after FDA issues a determination of equivalency.
* * * * *
Dated: November 30, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-30422 Filed 12-13-94; 8:45 am]
BILLING CODE 4160-01-P
