[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Notices]
[Pages 14789-14797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0025]
Medical Devices; Third-Party Review of Selected Premarket
Notifications; Pilot Program
AGENCY: Food and Drug Administration, HHS.
Action: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
voluntary pilot program to test the feasibility of using third-party
reviews to improve the efficiency of the agency's review of premarket
notifications for medical devices. To implement the pilot program, FDA
is announcing simplified agency procedures and practices to process
premarket notifications (510(k)'s) submitted by, and with a review
prepared by, third-party review organizations (third parties). In its
discretion, FDA will select third parties pursuant to the general
statements of policy with respect to competence and freedom from
conflicts of interest announced in this document. FDA recognizes that
it has long been common practice for some firms to engage third parties
to make a preliminary review and assist in the quality control of
documents prior to their submission in 510(k)'s. FDA believes a similar
third-party effort may be useful to improve the efficiency of the
agency's review process. The pilot program will allow FDA to evaluate
the feasibility of using the results of a third party's review in lieu
of the agency's initial review effort. This action is part of efforts
in pursuit of the reinventing Government goals of the National
Performance Review.
DATES: The pilot program will begin August 1, 1996, and will run for a
2-year period. FDA will apply the pilot program procedures to 510(k)'s
received during this period from recognized third parties. FDA is now
accepting applications for recognition of prospective third parties and
will continue to do so through June 3, 1996. To help prospective third
parties prepare these applications, FDA will hold an information
session for prospective third parties on April 15, 1996, to review the
third-party recognition process and criteria described in this notice,
and to answer related questions.
Submit written comments on the pilot program by June 3, 1996.
Submit written comments on the information collection requirements
by June 3, 1996. At FDA's request, the Office of Management and Budget
(OMB) authorized emergency processing of this information collection.
OMB approved the information collection for 90 days, under OMB control
no. 0910-0318.
ADDRESSES: Prospective third parties should submit an application for
recognition, in duplicate, to the Division of Small Manufacturers
Assistance (HFZ-220), ATTN: Third-Party Recognition, Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 1-800-638-2041 or 301-443-7491, both at ext.
105, or FAX 301-443-8818. 510(k)'s reviewed by third parties should be
submitted to the Document Mail Center (HFZ-401), ATTN: Third-Party
Review, Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
Written comments regarding the pilot program and the information
collection requirements may be submitted to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. Comments should be identified with the
docket number found in brackets in the heading of this document.
Persons interested in attending the information session for
prospective third parties should obtain registration information as
soon as possible. Copies of a facsimile containing this
[[Page 14790]]
information are available from the Center for Devices and Radiological
Health's (CDRH's) Facts on Demand system by dialing 1-800-899-0381 or
1-301-827-0111 and requesting document number 258. Internet users can
obtain registration information by using the World Wide Web; FDA's home
page address may be accessed at http://www.fda.gov and then select the
Medical Devices and Radiological Health option. Then select the Topic
Index option and then scroll down to the Third Party Review option.
Registration information is also available from the electronic docket
administered by the Division of Small Manufacturers Assistance and is
available to anyone with a video terminal or personal computer with a
modem (1-800-252-1366 or 1-301-594-2741) by making the following menu
choices: 2-Medical Devices Regulations; 8-Third Party Review FR Notice.
FDA encourages interested third parties to consider attending this
session. FDA will make an initial list of recognized third parties
publicly available before commencement of the pilot program, and will
update the list as changes occur.
A package of information explaining the Third Party Review Program
will be distributed at the information sesssion on April 15, 1996. If
you are unable to attend the information session and would like the
Third Party Review Program information package, please call 1-800-638-
2041 or 301-443-7491, both at ext. 105, or FAX 301-443-8818 with your
name and mailing address, and the package will be mailed after April
15, 1996.
FOR FURTHER INFORMATION CONTACT: Eric J. Rechen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
A. Purpose of Section 510(k)
The current regulatory framework for medical devices was created by
the Medical Device Amendments of 1976 (the amendments) to the Federal
Food, Drug, and Cosmetic Act (the act), as modified by the Safe Medical
Devices Act of 1990 and the Medical Device Amendments of 1992. The
amendments established in section 513(a) of the act (21 U.S.C. 360c(a))
three device classes and directed FDA to publish regulations
classifying each device on the market as of the amendments' enactment.
Classification is based on the level of control necessary to provide
reasonable assurance of the safety and effectiveness of a device. Class
I devices are subject only to general controls, including manufacturer
registration, device listing, 510(k), records and reports, and current
good manufacturing practice requirements. FDA may, by regulation,
exempt a class I device from certain of these requirements, including
510(k) requirements. Class II devices are subject to special controls
in addition to general controls, such as promulgation of performance
standards, postmarket surveillance, patient registries, and
dissemination of guidelines and recommendations. Class III devices are
subject to premarket approval and general controls. A preamendments
class III device is not required to undergo premarket approval until
the effective date of a regulation calling for premarket approval under
section 515 of the act (21 U.S.C. 360e).
Section 513(f) of the act contains special classification
provisions for postamendments devices. A device introduced on or after
the amendments' enactment date (May 28, 1976) is automatically in class
III and must receive premarket approval or be reclassified before
marketing unless it is substantially equivalent to a predicate device
(a device marketed before the amendments' enactment, or a device
introduced after the amendments' enactment that FDA has reclassified
from class III into class I or II).
Section 510(k) of the act provides a means to ensure that
manufacturers do not intentionally or unintentionally circumvent the
automatic classification provisions of Sec. 513(f). Under Sec. 510(k),
a person who intends to begin introduction of a device into commercial
distribution is required to report to FDA by submitting a 510(k) at
least 90 days in advance. FDA reviews 510(k)'s to determine if a new
device is substantially equivalent to a predicate device. For purposes
of determining substantial equivalence, a new device may also be
compared to a device that FDA has found to be substantially equivalent
through the 510(k) process. A device determined by FDA to be
substantially equivalent is in the same class and may be introduced to
the market subject to the same regulatory controls as the device to
which it is substantially equivalent. Before marketing the device, the
manufacturer must receive an order, in the form of a letter, by which
FDA finds the device to be substantially equivalent. A device
determined to be not substantially equivalent is automatically in class
III and must receive premarket approval or be reclassified before it is
marketed.
The meaning of the term ``substantially equivalent'' is discussed
in section 513(i) of the act. Substantial equivalence means, in
essence, that a device: (1) Has the same intended use and the same
technological characteristics as a predicate device; or (2) has the
same intended use and different technological characteristics, but
there is information in the 510(k) demonstrating that the device is as
safe and effective as a legally marketed device and the device does not
raise different questions of safety and effectiveness than the
predicate device. Substantial equivalence determinations are currently
made by scientific review staff within CDRH based primarily upon
information provided by a manufacturer's 510(k). FDA has published
regulations (part 807 (21 CFR part 807, subpart E)) specifying 510(k)
content and procedures. FDA has also developed numerous guidance
documents and policy memoranda for the 510(k) program that are
available from CDRH's DSMA, as discussed later in this notice.
Since the inception of the 510(k) program in 1976, FDA has received
more than 90,000 510(k)'s, approximately 6,000 of which were received
in fiscal year (FY) 1995. Approximately 80 percent of 510(k)'s have
resulted in substantially equivalent determinations, 2 percent in not
substantially equivalent determinations, and the remainder in
administrative actions such as withdrawal by the submitter or deletion
by FDA due to lack of response by a submitter. During the second half
of FY 1995, approximately 20 percent of substantially equivalent
determinations were for class I devices, 76 percent were for class II
devices, and 4 percent were for class III devices.
B. Initial Announcement of the Pilot Program
On April 6, 1995, FDA announced its intent to conduct a limited
pilot program of third-party review of selected 510(k)'s (hereinafter
referred to as the April announcement). This initiative is one aspect
of FDA's efforts in pursuit of the reinventing Government goals of the
National Performance Review. The purpose of the pilot program is to
test the feasibility of third-party review of selected 510(k)'s, as an
alternative to FDA's primary review.
In the Federal Register of June 1, 1995 (60 FR 28618), FDA
published a notice providing an outline of the proposed pilot program
(hereinafter referred to as the June 1 notice) and announcing a June
19, 1995, public workshop to
[[Page 14791]]
discuss the proposal. The June 1 notice and the April announcement
described key elements of the proposed pilot program:
FDA will designate the types of devices eligible for
third-party review. The devices will be in class I or II, involve low-
to moderate-risk, and have a clear basis for review. The pilot program
will exclude 510(k)'s requiring clinical data for a decision.
Third parties will be individually accepted by FDA. FDA
will outline criteria covering personnel qualifications and controls
over potential conflicts of interest.
Industry participation will be voluntary. A manufacturer
that chooses to participate will submit its 510(k) directly to a
recognized third party; the third party may assess a fee for its
services. Manufacturers that do not wish to participate may continue to
submit 510(k)'s to FDA.
The selected third party will conduct a complete review of
the 510(k), document the review, and make a recommendation to FDA. FDA
will check the review, make a substantial equivalence decision, and
issue a decision letter.
The pilot program will begin in FY 1996 and will operate
for 2 years. FDA will evaluate it during the second year to determine
whether it should be continued as is, modified, or terminated.
The June 19 public workshop provided a forum to discuss FDA's
proposed approach to implementing third-party review of selected
510(k)'s and a means of obtaining public comments and suggestions that
would help FDA refine its plans for the pilot program. Topics discussed
at the workshop included: The role of third parties; types of devices
eligible for third-party review; safeguards necessary to ensure the
quality and integrity of the pilot program; and funding of third-party
reviews. More than 200 persons attended the workshop, including
representatives of the device industry, potential third parties,
consumers, and health professionals. In addition to presentations and
comments at the workshop, FDA accepted written comments through July 7,
1995.
In general, these presentations and comments showed broad support
for a pilot program. Some industry representatives expressed concern,
however, about limitations on the pilot program that may restrict
manufacturers' incentive to participate. In particular, they commented
that including only low- to moderate-risk devices in the pilot program
and limiting third parties' role to making recommendations rather than
final decisions might result in marketing clearance decisions that are
no faster, and perhaps slower, than those made by FDA alone. In
addition, some industry representatives advocated: Standards-based
third-party reviews rather than reviews focused on substantial
equivalence; increased harmonization with international standards; and
reliance on existing accreditation systems and criteria for potential
third parties. Only a few manufacturers expressed opposition to the
pilot program, arguing that it would divert FDA's resources away from
other reviews or result in inconsistent marketing clearance decisions.
Potential third parties expressed strong interest in the pilot
program and indicated that they have the capability, independence, and
controls to conduct sound and unbiased reviews. Most advocated that FDA
rely on existing accreditation systems and criteria for potential third
parties, and that the setting of fees should be left to market forces.
Consumer and professional representatives recommended that FDA
proceed cautiously with the pilot program. They expressed concern that
third-party review could result in some loss of public accountability
and that effective controls are needed to ensure technically-competent
reviews free of any conflict of interest that could undermine the
objectivity of the review process.
In the months following the June 19 workshop, FDA has considered
all comments provided at the workshop and in response to the June 1
notice. FDA has attempted to incorporate suggestions to the extent that
they are consistent with existing statutory requirements and the pilot
program's purpose and timeframe. For example, while FDA continues to
believe that the pilot program should be limited to low- to moderate-
risk devices, FDA is significantly expanding the number of devices
(particularly in vitro diagnostics) eligible for third-party review and
is accepting the suggestion that there be a 30-day performance goal for
FDA's decisionmaking based on third-party reviews. Given that FDA's
cumulative review time is currently averaging approximately 90 days for
510(k) decisions involving class I devices (and is higher for other
510(k) decisions), a 30-day performance goal for FDA decisions under
the pilot program in conjunction with a timely third-party review
should provide a tangible incentive for manufacturers to participate in
the pilot program.
Similarly, while FDA is unaware of any existing accreditation
program for potential third parties that is directly suited to 510(k)
review--and is therefore unable to incorporate reliance on such an
accreditation for purposes of this pilot program--FDA is establishing a
streamlined process for third parties to seek participation in the
pilot program. This process should not present an undue burden to
qualified third parties that are ready to conduct reviews. However, FDA
will only recognize third parties that establish stringent criteria
regarding potential conflicts of interest. Having third parties who
establish such criteria--in conjunction with FDA's oversight of all
third-party reviews and potential for more indepth auditing--should
ensure the quality and integrity of 510(k) decisions made under the
pilot program.
FDA is not adopting the suggestion that it establish a specific
performance goal for the timeliness of reviews by third parties. FDA
believes such a goal is unnecessary because timeliness of third-party
reviews is likely to be a contractual matter between manufacturers and
third parties. In addition, market forces will provide an incentive for
third parties to perform timely reviews, i.e., timeliness will be an
important consideration when a manufacturer decides whether to submit a
510(k) to a particular third party or to FDA.
FDA has received suggestions that third parties be given final
decisionmaking authority under the pilot program and that third parties
conduct 510(k) reviews that are focused on criteria other than
substantial equivalence. FDA is not adopting these suggestions in the
pilot program. It is beyond the scope of the pilot program to test an
approach that is completely harmonized with other regulatory systems,
such as the third-party system of the European Union. The pilot program
does contain key elements of the European model, however, and will
provide information useful in assessing its potential applicability in
this country. FDA remains committed to the goal of global harmonization
and will continue to work with its regulatory counterparts toward that
end.
FDA welcomes further comments concerning the pilot program. FDA
will use comments to make necessary adjustments during implementation
of the pilot program and to conduct an evaluation.
[[Page 14792]]
II. Outline of the Third-Party Review Pilot Program
A. Purpose
The overall purpose of the pilot program is to determine whether it
is feasible for third parties in the private sector to conduct selected
510(k) reviews that, until now, have been conducted by FDA. This
includes determining:
The willingness of qualified third parties to participate;
The willingness of manufacturers to submit 510(k)'s to a
third party;
The quality, timeliness, and independence of third-party
reviews; and
Any discernable impacts on FDA resource needs, review
times, and decisions, and on the total time needed for manufacturers to
obtain 510(k) decisions.
If the pilot approach proves successful, it will: (1) Enable FDA to
target its scientific review resources at higher-risk devices while
maintaining a high degree of confidence in the review by third parties
of low- to moderate-risk devices; and (2) provide manufacturers of
eligible devices an alternative review process that can yield more
rapid 510(k) decisions. FDA intends the pilot program to test the
feasibility of attaining these outcomes.
The pilot program includes safeguards to maintain a high level of
quality in the review of 510(k)'s submitted to third parties.
Participation in the pilot is entirely voluntary. Manufacturers may
continue to submit 510(k)'s directly to FDA. Manufacturers may also
employ the assistance of third parties other than those recognized by
FDA, but only 510(k)'s reviewed by recognized third parties will be
eligible for the pilot program's simplified processing procedures.
Although the guidance set forth in this notice does not create or
confer any rights on any person, and does not operate to bind FDA in
any way, it does represent the agency's current thinking on third-party
review of 510(k)'s.
B. Devices Eligible for Third-Party Review
During the pilot program, 510(k)'s for the following two categories
of devices will be eligible for review by third parties, except when a
determination of substantial equivalence necessitates review of
clinical data:
All class I devices that are not exempt from 510(k); and
Class II devices designated by FDA for inclusion in the
pilot program, for which FDA has made device-specific review guidance
available.
There are more than 200 types of devices classified by FDA in class
I that have not been exempted from 510(k), many of which are in vitro
diagnostic devices. FDA is making available a list of these devices
(see section III of this document for information on obtaining a copy).
FDA currently receives approximately 1,100 510(k)'s per year for these
devices.
FDA is also making available a preliminary list of class II devices
that it intends to include in the pilot program (see section III of
this document for information on obtaining a copy of the list or any
associated review guidance). Prior to commencement of the pilot
program, and on a quarterly basis during the program's first year, FDA
will make review guidance available for a portion of the devices on the
list and will update the list to designate those devices as being
eligible for third-party review. FDA intends all of the class II
devices on the preliminary list to be eligible for third-party review
by the end of the first year of the pilot program, but this may be
affected by factors such as workload or resource changes in CDRH's
Office of Device Evaluation and the extent or nature of public comments
received in the development of guidance documents.
Any 510(k) for which clinical data are needed to make a
determination of substantial equivalence will continue to be subject to
primary review by FDA and will not be processed by FDA under the
special procedures for this pilot program. 510(k)'s for the above two
categories of devices normally do not contain clinical data and will
typically be candidates for inclusion in the pilot program. The need
for clinical data is, however, a matter of expert judgment and is often
dependent on the nature of any differences (e.g., new indications for
use) between the new device and the device to which it is being
compared. Manufacturers and third parties seeking guidance on the need
for clinical data in a 510(k) should consult FDA's guidance documents
and may also contact the appropriate review division in CDRH's Office
of Device Evaluation.
C. Recognition of Third Parties
FDA will recognize those third parties whose reviews of 510(k)'s it
will consider during the pilot program. While the number of third
parties to be recognized by FDA will necessarily be dependent on the
number of qualified applicants and the extent of their review
capabilities, FDA believes that participation by 3 to 10 recognized
third parties would be sufficient for purposes of the pilot program and
would keep the pilot program within manageable limits. When selecting
third parties for recognition, FDA will give foremost consideration to
those third parties with the most qualified personnel and the most
stringent conflict of interest standards that are capable of reviewing
a broad range of device types or that are uniquely capable of reviewing
specific types of devices. FDA will consider recognition requests from
both domestic and foreign third parties.
CDRH will maintain a list of third parties eligible to submit
510(k) reviews to FDA. This list will provide the name, contact person,
address, telephone number, and specialty (if any) of organizations that
FDA has recognized for participation as third parties in the pilot
program.
FDA is announcing that it intends to hold an information session
for prospective third parties on April 15, 1996, in Rockville, MD, to
review the third-party recognition process and criteria described in
this notice, and to answer related questions. FDA encourages interested
third parties to consider attending this session before submitting a
request for recognition. Persons interested in attending should obtain
registration information as soon as possible. Copies of a facsimile
containing this information are available from CDRH's Facts on Demand
system by dialing 1-800-899-0381 or 1-301-827-0111 and requesting
document number 258. Internet users can obtain registration information
by using the World Wide Web; FDA's home page address may be accessed at
http://www.fda.gov and then select the Medical Devices and Radiological
Health option. Then select the Topic Index option and then scroll down
to the Third Party Review option. Registration information is also
available from the electronic docket administered by the Division of
Small Manufacturers Assistance and is available to anyone with a video
terminal or personal computer with a modem (1-800-252-1366 or 1-301-
594-2741) by making the following menu choices: 2-Medical Device
Regulations; 8-Third Party Review FR Notice.
Qualified organizations that wish to become a recognized third
party for the pilot program should submit the following materials, in
duplicate, no later than June 3, 1996:
1. Information identifying the third party, including its name,
contact person, address, telephone number, and fax number. A third
party located outside the United States should also
[[Page 14793]]
identify the name, address, telephone number, and fax number of an
authorized representative located within the United States who will
serve as the third party's official correspondent with FDA.
2. Identification of the devices the third party seeks to review.
If a third party seeks to review only a subset of the devices eligible
for third-party review under this pilot program, the devices should be
clearly identified, such as by classification panel (i.e., all eligible
devices within the panel) or by specific classification name and Code
of Federal Regulations citation.
3. Documentation that the third party meets its established
criteria, as described in section II.D.1. and II.D.2. of this document,
with respect to personnel qualifications and facilities.
4. A copy of the written policies and procedures established by the
third party to ensure that it and its employees involved in the third-
party review of 510(k)'s are free from conflicts of interest, as
outlined in section II.D.3. of this document, and certification that
the third party and its employees meet its established criteria.
5. A statement that the third party consents to FDA inspection and
copying of all records, correspondence, and other materials relating to
any review conducted by the third party under this pilot program,
including records on personnel education, training, skills, and
experience, all documentation on prevention of conflicts of interest,
and the third party's fee schedule and invoices for conducting 510(k)
reviews.
6. A statement that the third party will strictly preserve and
protect the confidentiality of all information provided by any
manufacturer and by FDA.
When these materials are received by DSMA, a date-stamped
acknowledgment letter will be faxed to the third party's official
correspondent. DSMA will coordinate CDRH's review of these materials
and respond to the third party within 30 days of the completion of the
time period for submitting such materials with one of the following: A
letter of recognition, a denial of recognition, or a request for
additional information. CDRH may deny a request for recognition for any
reason, including if it determines that the third party's personnel
qualifications or criteria for ensuring conflicts of interest are
inadequate, or if the third-party's submission does not place it among
the most highly qualified candidates. CDRH may deem incomplete and
delete a request for recognition if a third party fails to respond to a
request for additional information within 10 days. Third parties may
make a written request to the Director, Office of Health and Industry
Programs, CDRH for reconsideration of a decision to deny or delete a
request for recognition.
A list of recognized third parties will be made available to the
public through CDRH's Facts-on-Demand facsimile system (1-800-899-0381,
document number 967), or the electronic docket (1-800-252-1366) (see
section III. of this document for information on obtaining a copy)
before commencement of the pilot program. The list will be updated as
necessary and will be made available for the duration of the pilot
program.
Unless the third party requests that it be removed from FDA's
recognition list, or FDA finds for any reason in its sole discretion--
including that the third party has not followed recognized rules of
ethics or conduct, is not in fact independent, or has knowingly made
any material misstatement of fact or circumstances or material
misrepresentations of any kind--that the third party is no longer
qualified, recognition will continue for the duration of the pilot
program. If changes occur that significantly affect any information or
certification provided to FDA, it is the responsibility of the third
party to provide FDA with updated information and, if necessary, an
updated certification, at the earliest possible opportunity.
If FDA has reason to believe that a recognized third party no
longer meets the criteria for participation in the pilot program, an
opportunity for a meeting with the Director, Office of Health and
Industry Programs, CDRH, will be provided prior to any decision
concerning removal of the third party from FDA's list of recognized
third parties.
Consistent with current practice, FDA will accept 510(k)'s from
third parties that have not been recognized, but FDA will give no
weight to any review or recommendation provided by the nonrecognized
third party and will treat the submission in the same manner as a
510(k) submitted by a consultant.
D. Criteria for Third Parties
To be recognized by FDA, a third party should demonstrate that it
has the appropriate qualifications and facilities to conduct competent
510(k) reviews, and has instituted effective controls to prevent any
conflict of interest or appearance of conflict of interest that might
affect the review process.
1. Personnel Qualifications
FDA expects to recognize third parties that have sufficient
personnel, with the necessary education, training, skills, and
experience, to evaluate a substantial number of 510(k)'s in those
categories of devices it accepts for review. FDA will consider several
factors with respect to personnel qualifications when it considers who
to recognize as third parties. These include:
(a) Whether the third party has established, documented, and
executed policies and procedures to ensure that 510(k)'s are reviewed
by qualified personnel, and whether it will maintain records on the
relevant education, training, skills, and experience of all personnel
who contribute to the technical review of a 510(k);
(b) Whether the third party has made available to its personnel
clear, written instructions for their duties and responsibilities with
respect to 510(k) reviews;
(c) Whether the third party employs personnel who, as a whole, are
qualified in all of the scientific disciplines addressed by the
510(k)'s that the third party accepts for review;
(d) Whether the third party has identified at least one individual
who is responsible for providing supervision over 510(k) reviews and
who has sufficient authority and competence to assess the quality and
acceptability of these reviews; and
(e) Whether the third party is prepared to conduct technically
competent reviews at the time of requesting recognition by FDA.
FDA is making available information on the general education and
experience FDA requires of its scientific review personnel (see section
III. of this document for information on obtaining a copy). Within
CDRH's Office of Device Evaluation, the GS-12 level (as described in
the information being made available) is usually considered to be the
typical level at which reviewers assume full responsibility for
conducting 510(k) reviews. A third party may adopt these criteria as
one means of ensuring that its personnel having primary responsibility
for review of a 510(k) for a class I device have appropriate education
and experience. A third party may develop and apply alternative
criteria that result in personnel having education and experience
necessary and appropriate to review 510(k)'s for class I devices.
For appropriate review of a particular class II device, FDA will
expect specialized education or experience consistent with assuring a
technically competent review.
2. Facilities
FDA expects to recognize third parties that have the capability to
interface with
[[Page 14794]]
FDA electronic data systems. At a minimum, this would include a
computer system with a modem and an independent facsimile machine.
3. Prevention of Conflicts of Interest
FDA expects to recognize third parties that will be impartial and
free from any commercial, financial, and other pressures that might
present a conflict of interest or an appearance of conflict of
interest. To that end, when deciding whether to recognize a third
party, FDA will consider whether the third party has established,
documented, and executed policies and procedures to prevent any
individual or organizational conflict of interest. Although it is not
feasible to identify or state categorically or inflexibly all of the
criteria for judging that a third party is free of conflicts of
interest, the most common conditions that would indicate a potential
conflict of interest are:
(a) The third party is owned, operated, or controlled by a device
manufacturer or distributor;
(b) The third party or any of its personnel involved in 510(k)
reviews has any ownership or other financial interest in any medical
device, device manufacturer, or distributor;
(c) The third party or any of its personnel involved in 510(k)
reviews participates in the design, manufacture, or distribution of any
medical device;
(d) The third party or any of its personnel involved in 510(k)
reviews provides consultative services to any device manufacturer or
distributor regarding any specific devices;
(e) The third party or any of its personnel involved in 510(k)
reviews participates in the preparation of any 510(k); or
(f) The fee charged or accepted by the third party is contingent or
based upon the type of recommendation made by the third party.
Nevertheless, a third party may: Assess a fee for its services;
conduct other activities, such as objective testing or inspection of
devices, if they do not affect the impartiality of 510(k) reviews; and
provide information on 510(k) requirements to improve the organization
or content of a 510(k) that it is reviewing.
Where a third party uses the services of a contractor for 510(k)
reviews, the third party is responsible for the contracted work of its
contractor. The third party is to assure that the contractor meets the
third party's established criteria for freedom from conflicts of
interest.
FDA is making available information on the conflict of interest
standards it applies to its own review personnel (see section III. of
this document for information on obtaining a copy). A third party may
adopt these standards as one means of safeguarding its operations
against conflicts of interest.
FDA has considered additional mechanisms to ensure the independence
of recognized third parties and to prevent even the appearance of forum
shopping by manufacturers. One mechanism considered would be for
manufacturers to submit their 510(k)'s first to FDA and then have the
agency assign submissions to recognized third parties that are
qualified to review them, much like FDA now assigns submissions to
internal staff reviewers. Under this mechanism, manufacturers would
then negotiate a fee with the third party and pay the fee directly.
Although this mechanism would likely be effective in guarding against
forum shopping, it has the major disadvantage, for purposes of the
pilot program, of necessitating that FDA establish a special processing
and assignment system for what could be a relatively large number of
510(k)'s submitted in the short period of the pilot program. It also
would restrict manufacturers' ability to negotiate fees, and limit
other potentially beneficial competitive influences on the pilot
program.
Accordingly, for purposes of this pilot program, manufacturers are
to contact recognized third parties directly to request review of their
510(k)'s. FDA may refuse, however, to provide expedited processing of a
manufacturer's 510(k)'s and consideration of the accompanying third-
party reviews if it appears to FDA, in its sole discretion, that the
manufacturer has engaged in forum shopping. Although it is not feasible
to identify or state categorically all of the criteria for evaluating
whether a manufacturer has forum shopped, three factors that would
indicate forum shopping are:
A manufacturer has obtained reviews of the same 510(k)
from more than one third party, or from a third party and directly from
FDA;
A manufacturer has contracted for a substantial number of
third-party reviews (ordinarily more than 10 in 1 year) from the same
third party when other recognized third parties have the necessary
expertise and capacity to perform additional 510(k) reviews; or
A manufacturer has contracted for reviews from the same
third party the sum of fees for which is substantial (ordinarily
exceeding $50,000 in 1 year) when other recognized third parties have
the necessary expertise and capacity to perform additional 510(k)
reviews.
If one (or more) of these factors is present, there will be a
presumption of forum shopping and FDA may refuse to provide expedited
processing of a manufacturer's 510(k)'s unless the manufacturer can
explain why the circumstances do not indicate forum shopping.
Manufacturers' avoidance of the last two factors will have the added
benefit of enhancing manufacturers' ability to contribute to the
evaluation of the pilot program, i.e., manufacturers that contract with
more than one third party during the course of the pilot program will
have a better basis for assessing how each performs.
E. Purpose and Nature of a Third-Party Review
The purpose of a third-party review is to evaluate a manufacturer's
510(k), document the review, and make a recommendation to FDA
concerning the substantial equivalence of the device. FDA will provide
information on procedures and criteria that it uses for 510(k) reviews
in general guidance and in a training program to be made available by
FDA before commencement of the pilot program (see section III. of this
document for information on obtaining a copy of FDA's general review
guidance). Until then, interested persons may consult existing guidance
such as HHS Publication FDA 95-4158 ``Premarket Notification 510(k)--
Regulatory Requirements for Medical Devices'' (August 1995). This
publication provides an overview of device regulations, information on
510(k), FDA requirements concerning 510(k) content and format, a
description of the 510(k) review process, copies of particularly
important policy memoranda, and additional information useful to
manufacturers and third parties. A copy of this publication may be
obtained by contacting CDRH's DSMA (see section III. of this document
for additional information on obtaining a copy).
FDA encourages third parties to be familiar with the requirements
outlined in this publication and in subsequent guidance. The general
guidance, as well as any device-specific review guidance made available
by FDA, will assist the third party in producing reviews that are
acceptable to FDA and that FDA can process in a timely manner.
F. Training for Recognized Third Parties
FDA is currently planning to hold one or more training sessions for
recognized third parties. (This training is in addition to the
prerecognition information session discussed earlier in
[[Page 14795]]
this notice.) Recognized third parties are to complete this training
before conducting 510(k) reviews under the pilot program. The primary
emphasis of this training will be on how to conduct an appropriate
review of a 510(k). Depending on demand, one or more sessions may focus
on specific types of devices, such as in vitro diagnostic devices. FDA
will provide additional information on this training when it sends
letters of recognition to third parties participating in the pilot
program.
G. Review Materials to be Submitted to FDA by a Third Party
Upon completion of its review of a 510(k), a third party should
submit the following documentation to FDA, in duplicate:
1. A cover letter signed by the third party's official
correspondent clearly identifying: the purpose of the submission; the
name and address of the third party; the name and address of the
manufacturer; the name of the device (trade name, common or usual name,
and FDA classification name); the third party's recommendation with
respect to the substantial equivalence of the device; and the date the
third party first received the 510(k) from the manufacturer.
2. A letter signed by the manufacturer authorizing the third party
to submit the 510(k) to FDA on its behalf and to discuss its contents
with FDA.
3. The manufacturer's complete 510(k) conforming to FDA's
established requirements relating to content and form of such
submissions.
4. A complete review of the 510(k), signed by all personnel who
conducted the third-party review and by an individual within the third
party responsible for supervising third-party reviews, with a
recommendation concerning the substantial equivalence of the device.
5. A certification that the third party continues to meet the
personnel qualifications and prevention of conflict of interest
criteria reviewed by FDA; that statements made in the third party's
review are true and accurate to the best knowledge of the third party;
that the third party's review is based on the 510(k) that it is
submitting with the review; and that the third party understands that
the submission to the government of false information is prohibited by
18 U.S.C. 1001 and 21 U.S.C. 331(q).
6. Any other information requested in FDA's guidance for third
parties.
FDA may not process a 510(k) submitted with a third-party review if
this documentation is not included with the submission. Third-party
reviews, along with the associated 510(k)'s, should be submitted to
CDRH's Document Mail Center (address above). If a part of the material
submitted is in a foreign language, it should be accompanied by an
English translation verified to be complete and accurate.
H. Basic Document Processing
To ensure the integrity of the review process, all third-party
review materials and the associated 510(k) are to be submitted directly
to FDA by the third party. CDRH's Document Mail Center will receive all
submissions, and will then route them to the appropriate review
division in CDRH's Office of Device Evaluation. 510(k)'s reviewed and
submitted by recognized third parties will bypass the first phases of
FDA's normal review process, that is, the acceptance screening and
initial scientific review, and will instead be routed directly to the
appropriate supervisory official, typically a branch chief. The
supervisory official will rely in part on the record of review prepared
by the third party and will conduct a brief administrative assessment
to determine whether the third party's review is acceptable to FDA.
This assessment will apply the same criteria as for 510(k)'s reviewed
entirely within FDA. If FDA has questions concerning the submission,
the third party will be contacted. The supervisory official will
prepare FDA's decision concerning the substantial equivalence of the
device. Decision letters and other significant correspondence will be
sent to the third party's official correspondent, which will be
responsible for communicating with the manufacturer. FDA is
establishing a 30-day performance goal for its decisions on 510(k)'s
received under the pilot program.
As noted earlier, 510(k)'s submitted by third parties that have not
been recognized by the agency will be accepted, but those submissions
will not be eligible for processing under the pilot program's
simplified procedures. Any such 510(k) will be processed in the same
manner as a normal 510(k) submitted by a consultant.
I. Confidentiality of Information
A recognized third party is to conscientiously preserve and protect
the confidentiality of all information provided to it by a manufacturer
or by FDA. Except for authorized FDA employees or as otherwise provided
by Federal or State law, no information pertaining to any review,
including its existence, is to be made available to any person without
the express written permission of the manufacturer employing the third
party and written permission by FDA.
The releasability of third-party review information submitted to
FDA will be determined by FDA in accordance with the agency's
regulations (part 20 (21 CFR part 20) and Sec. 807.95) implementing the
Freedom of Information Act and related acts. In general, 510(k) reviews
submitted by third parties (just like reviews conducted by FDA staff)
will be available for disclosure by FDA after FDA has issued a
substantial equivalence decision for a device, unless the information
is exempt from public disclosure under part 20. If necessary, a review
will be provided to the manufacturer for predisclosure notification
pursuant to Sec. 20.61. In addition, information submitted by a third
party to obtain FDA's recognition for participation in the pilot
program will be available for disclosure by FDA, unless exempt under
part 20.
J. Records
A recognized third party should maintain complete records of its
510(k) reviews and other information necessary for participation in the
pilot program. These records include documentation of the third party's
policies and procedures under section II.D. of this document with
respect to personnel qualifications and prevention of conflicts of
interest; copies of all correspondence and other information to become
recognized by FDA; copies of all 510(k) reviews, the associated
510(k)'s, and related correspondence with manufacturers and FDA;
information on the identity and qualifications of all personnel who
contributed to the technical review of each 510(k); and the third
party's fee schedule and invoices for conducting 510(k) reviews.
Records should be in English or be accompanied by a complete and
accurate English translation. Records should be retained for a
reasonable period of time, but no less than 3 years following
submission of a review to FDA. All records are subject to FDA
inspection and copying.
K. Fees Assessed by Third Parties
Recognized third parties may assess a reasonable fee for their
services. The fee for a third-party review is a matter to be determined
by contract between the third party and the manufacturer, but will be
considered by FDA to present a conflict of interest if it is contingent
or based upon the type of recommendation made by the third party. As
indicated above, the third party's fee schedule and invoices for
conducting 510(k) reviews are subject to FDA inspection and copying.
[[Page 14796]]
L. Dates and Duration of the Pilot Program
The pilot program will begin August 1, 1996, and will run for a 2-
year period. FDA will apply the pilot program procedures to 510(k)'s
received during this period from recognized third parties. FDA is now
accepting applications for recognition of prospective third parties and
will continue to do so through June 3, 1996. FDA will closely monitor
the operation of the pilot program and may modify its scope or
conditions if necessary to protect the public health or to better
achieve program objectives. During the second year of the pilot
program, FDA will evaluate the pilot program and FDA will then
determine whether it should be continued as is, modified, or
terminated. FDA intends to complete this evaluation prior to the
scheduled ending date for the pilot program.
M. Safeguards
The pilot program includes a number of safeguards to maintain a
high level of quality in 510(k)'s reviewed by recognized third parties
and to minimize risks to the public. Most of these safeguards have been
discussed above, and are briefly listed here:
Limitation of the pilot program to low- to moderate-risk
class I or class II devices for which FDA has made review guidance
available;
Exclusion of any 510(k) that requires clinical data for a
determination of substantial equivalence;
FDA assessment and recognition of third parties before
their participation in the pilot program;
Personnel qualifications for third parties equivalent to
the level within CDRH's Office of Device Evaluation;
Criteria to prevent potential conflicts of interest that
might affect the review process;
FDA training for recognized third parties;
FDA review of third-party reviews/recommendations and
FDA's continued responsibility for the issuance of 510(k) decisions;
Provision for FDA inspection of records, correspondence,
and other materials relating to any third-party review;
FDA monitoring and evaluation of the pilot program; and
Continued applicability of any other regulatory controls
(e.g., medical device reporting of post-marketing adverse events)
normally applicable to devices included in the pilot program.
III. Obtaining Additional Information
Additional information on the pilot program can be obtained by
contacting CDRH's DSMA at 1-800-638-2041 or 301-443-7491, both at ext.
105, or FAX 301-443-8818. Some information will only be available on
the DSMA Facts-on-Demand facsimile system, which is accessed by touch-
tone telephone or on the DSMA Electronic Docket, which is accessed via
a computer with a modem. Information that DSMA will make available
includes:
This notice;
Registration information for the information session to be
held on April 15, 1996, in Rockville, MD, to review the third-party
recognition process and criteria for prospective third parties;
A checklist for third parties seeking FDA recognition;
Information on the general education and experience
requirements for FDA personnel involved in the technical review of
510(k)'s;
Information on the conflict of interest standards FDA
applies to its employees;
A list of recognized third parties, updated as necessary
(this information will only be available from the DSMA Facts-on-Demand
system (1-800-899-0381, document number 967) or Electronic Docket (1-
800-252-1366);
A list of the devices eligible for third-party review,
updated at least quarterly;
Device-specific guidance for class II devices designated
as eligible for third-party review;
General guidance on 510(k) requirements and the content
and format of third-party reviews; and
Any additional information and guidance that FDA finds
necessary or appropriate as the pilot program proceeds.
IV. Paperwork Reduction Act of 1995
This voluntary pilot program contains information collections which
are subject to review by OMB under the Paperwork Reduction Act of 1995
(Pub. L. 104-13). At the agency's request, OMB conducted an emergency
review of this information collection, as provided for under 5 CFR
1320.13. OMB approved the information collection within 10 days, as
requested by FDA, for the maximum 90 days permitted under 5 CFR
1320.13, under OMB control no. 0910-0318. Persons are not required to
respond to a collection of information unless it displays a currently
valid OMB control number.
Because the OMB emergency approval of this information collection
is valid for only 90 days, FDA is also taking the appropriate steps to
obtain a regular approval. Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each collection of information. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).
To comply with this requirement, FDA is publishing a notice of the
information collection. The title, description, and respondent
description of the information collection are shown below with an
estimate of the annual reporting and recordkeeping burden. Included in
the estimate is the time for reviewing instructions, searching data
sources, gathering and maintaining the date needed, and completing and
reviewing the collection of information.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility; (2) the
accuracy of the agency'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 those who are to
respond, including through the use of automated collection techniques,
when appropriate, and other forms of information technology.
Title: Medical Devices; Third-Party Review of Selected Premarket
Notifications; Pilot Program
Description: This Federal Register notice announces a 2-year,
voluntary pilot program to test the feasibility of using third-party
reviews to improve the efficiency of FDA's review of premarket
notifications under section 510(k) of the act. Participation is
entirely voluntary. A third party wishing to participate will submit a
request for recognition within 60 days of publication of the Federal
Register notice. After reviewing a manufacturer's 510(k), a third party
is to forward the 510(k) along with the third party's documented review
and recommendation to FDA. Third parties should maintain records of
their 510(k) reviews for a reasonable period of time, but no less than
3 years. This information collection will enable FDA to conduct a
voluntary pilot program to determine the feasibility of third-party
review of 510(k)'s to improve the efficiency of FDA's review of
510(k)'s for low- to moderate-risk devices.
Description of Respondents: Businesses or other for-profit, not-
for-profit institutions.
[[Page 14797]]
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Table 1.--Estimated Annual Reporting Burden for Third Parties
---------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours Per Total Total Capital Total Operating &
Section Respondents Response Responses Response Hours Costs Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
II.C.1-5 (Recognition Requests):
First Submission 15 0.51 7.5 24 180 ............. ....................
Additional information 8 0.51 4.0 4 16 ............. ....................
Updates 10 1.0 10.0 1 10 ............. ....................
510(k) Reviews
II.G.1-6 10 50 500 40 20,000 57,250 28,625
Total .............. ..................... ............. ............. 20,206 57,250 28,625
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\These submissions are made in the first year only, the reporting frequency has been averaged over the pilot program's 2-year period to provide an
annual frequency.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2.--Estimated Annual Recordkeeping Burden
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Operating & Maintenance
Section No. of Recordkeepers Recordkeeping Total Annual Records Hours Per Recordkeeper Total Hours Total Capital Costs Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
II.J. 10 252 2,520 63 630 .................... .............................
........................ ........................... .................... ........................ ................. .................... .............................
........................ ........................... .................... ........................ ................. .................... .............................
........................ ........................... .................... ........................ ................. .................... .............................
........................ ........................... .................... ........................ ................. .................... .............................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Capital costs and operating and maintenance costs are attributable
to reporting and are included in the table above.
Organizations and individuals may submit comments regarding this
information collection, including suggestions for reducing this burden,
by June 3, 1996, and should direct them to the Dockets Management
Branch (address above).
Dated: March 25, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-8149 Filed 4-1-96; 8:45 am]
BILLING CODE 4160-01-F
