[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Notices]
[Pages 28388-28391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13799]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices; Implementation of Third Party Review Under the
Food and Drug Administration Modernization Act of 1997; Emergency
Processing Request Under OMB Review
[Docket No. 98N-0331]
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a program
under which persons may be accredited to review premarket notifications
and recommend initial classification of certain medical devices. At the
same time, FDA is announcing the termination of the Third Party Review
Pilot Program. This notice announces the criteria to accredit or deny
accreditation to persons (Accredited Persons) who request to conduct
premarket notification reviews consistent with provisions of the FDA
Modernization Act of 1997 (FDAMA). FDA is also announcing that this
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). FDA is requesting OMB
approval within 45 days of receipt of this submission. FDA is taking
this action to implement section 210 of FDAMA. The availability of
guidance detailing the review of submissions, training for third party
reviewers, and basic document processing by FDA is announced elsewhere
in this issue of the Federal Register.
DATES: Submit written comments on the collection of information by June
22, 1998. FDA will begin accepting applications for accreditation of
Accredited Persons on July 20, 1998, and intends to make a list of
Accredited Persons available on or about September 23, 1998. Beginning
November 21, 1998, the agency will accept reviews and recommendations
from Accredited Persons. On that same date, FDA plans to terminate the
Third Party Review Pilot Program that began on August 1, 1996. FDA is
currently planning to provide periodic training sessions for Accredited
Persons, with the first such session scheduled for October 14-16, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW, rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: John F. Stigi, Division of Small
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850, 301-443-6597, FAX 301-443-8818.
SUPPLEMENTARY INFORMATION:
I. Background
A. Third Party Review Pilot Program
In the Federal Register of April 3, 1996 (61 FR 14789), FDA
announced that it would begin a 2-year voluntary pilot program to test
the feasibility of using third party reviewers to improve the
efficiency of the agency's review of 510(k)'s for selected low-and-
moderate risk medical devices. FDA had previously solicited public
comments on its plans for the pilot program in a notice issued in the
Federal Register of June 1, 1995 (60 FR 28618), and at a public
workshop held June 19, 1995. The comments received by the agency were
addressed in the Federal Register notice (61 FR 14789).
The program announced in the April 3, 1996, notice provided for
third party review for 251 types of devices that were included in the
pilot program. These included all class I devices that were not exempt
from 510(k) at that time (221 devices), and 30 class II devices, 24 of
which were to be phased into the program over time.
Under the pilot program, persons required to submit 510(k)'s for
the eligible devices were permitted to contract with an FDA Recognized
Third Party and submit a 510(k) directly to the third party for review.
Persons who did not wish to participate in the pilot continued to
submit 510(k)'s directly to FDA. The third party applied FDA's 510(k)
review criteria and submitted its documented review and recommendation
on the substantial equivalence of the device to FDA. FDA then checked
the review and issued a decision letter. FDA established a 30-day
performance goal for its issuance of final decisions based on third
party reviews.
The purpose of the pilot program was to: (1) Provide manufacturers
of eligible devices with an alternative review process that could yield
more rapid marketing clearance decisions, and (2) enable FDA to target
its scientific review resources at higher-risk devices while
maintaining confidence in the review by third parties of low-to-
moderate risk devices. The pilot program was intended to determine the
feasibility of these outcomes.
The agency received applications for recognition as third party
reviewers from 37 prospective third parties. These applications were
reviewed by a Third Party Recognition Board established by FDA. On July
11, 1996, FDA made publicly available a list of seven Recognized Third
Parties, and immediately began a training program for third party
review.
The pilot program began August 1, 1996, as scheduled. During the
first 18 months of the pilot program, FDA received 22 510(k)'s that
were reviewed by Recognized Third Parties. In contrast, during the same
period, FDA received more than 1,300 510(k)'s for third party-eligible
devices that were not reviewed by third parties.
B. FDA Modernization Act of 1997
The President signed FDAMA into law on November 21, 1997. Section
210 of FDAMA codifies and expands the ongoing Third Party Review Pilot
Program by establishing a new section 523 of Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit
persons in the private sector to conduct the initial review of 510(k)'s
for selected low-to-moderate risk devices. This section specifies that
an Accredited Person may not review class III devices or class II
devices that are permanently implantable, life-supporting, life-
sustaining, or for which clinical data are required. This section also
sets limits on the number of class II devices requiring clinical data
that may be ineligible for Accredited Person review.
II. FDAMA Third Party Review Program
Under the provisions of FDAMA, FDA is establishing the criteria it
will use to determine whether it will accredit or deny accreditation of
persons for the purpose of reviewing reports submitted under section
510(k) of the act (21 U.S.C. 360(k)) and making recommendations to FDA
regarding the initial classification of devices under section 513(f)(1)
of the act (21 U.S.C. 360c(f)(1)). As intended by Congress,
[[Page 28389]]
this process is an expansion of FDA's Third Party Review Pilot Program.
This expanded program is applicable to a greater number and variety of
devices. To ensure accurate and timely review, Accredited Persons will
be expected to consult review guidance or national and/or international
standards recognized by FDA. FDA is making available on the CDRH home
page on the World Wide Web a list of devices for which there are
recognized standards or review guidance and which will be eligible for
review by Accredited Persons. FDA will update the list regularly.
To be accredited by FDA, applicants must demonstrate that they have
the appropriate qualifications and facilities to conduct competent
510(k) reviews and have instituted effective controls to prevent any
conflict of interest or appearance of conflict of interest that might
affect the review process.
In accordance with FDAMA, to be accredited by FDA an applicant
must, at a minimum, have the following qualifications:
(1) An Accredited Person may not be a Federal Government employee;
(2) An Accredited Person shall be an independent organization not
owned or controlled by a manufacturer, supplier, or vendor of devices
and have no organizational, material, or financial affiliation with
such a manufacturer, supplier, or vendor;
(3) An Accredited Person shall be a legally constituted entity
permitted to conduct the activities for which it seeks accreditation;
(4) An Accredited Person shall not engage in the design,
manufacture, promotion, or sale of devices;
(5) An Accredited Person shall operate in accordance with generally
accepted professional and ethical business practices and agree in
writing that, at a minimum, it will:
(a) Certify that reported information accurately reflects data
reviewed;
(b) Limit work to that for which competence and capacity are
available;
(c) Treat information received, records, reports, and
recommendations as proprietary information;
(d) Promptly respond and attempt to resolve complaints regarding
its activities for which it is accredited; and
(e) Protect against the use of any officer or employee of the
Accredited Person who has a financial conflict of interest regarding
the device, and annually make available to the public disclosures of
the extent to which the Accredited Person, and the officers and
employees of the Accredited Person, have maintained compliance with
requirements relating to financial conflicts of interest.
In accordance with FDAMA, an Accredited Person also must, at a
minimum, maintain records that support its initial and continuing
qualifications to be an Accredited Person. These records include:
(1) Documenting the training qualifications of the Accredited
Person and the employees of the Accredited Person;
(2) The procedures used by the Accredited Person for handling
confidential information;
(3) The compensation arrangements made by the Accredited Person;
and
(4) The procedures used by the Accredited Person to identify and
avoid conflicts of interest.
In addition to the above minimum requirements for Accredited
Persons, FDA is establishing the following:
1. Personnel Qualifications
FDA expects to consider several factors with respect to personnel
qualifications when it considers accrediting applicants. These include:
(1) Whether the applicant's personnel have demonstrated knowledge
of:
The Federal Food, Drug, and Cosmetic Act (21 U.S.C., 301
et seq.);
The Public Health Service Act (42 U.S.C., 201 et seq.);
and
The regulations implementing these statutes, particularly
21 CFR parts 800 through 1299.
(2) Whether the applicant:
Has established, documented, and executed policies and
procedures to ensure that 510(k)'s are reviewed by qualified personnel,
and will maintain records on the relevant education, training, skills,
and experience of all personnel who contribute to the technical review
of a 510(k);
Has clear written instructions for duties and
responsibilities with respect to 510(k) reviews available to its
personnel;
Has employed personnel who, as a whole, are qualified in
all of the scientific disciplines addressed by the 510(k)'s that the
Accredited Person accepts for review;
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
Is prepared to conduct technically competent reviews at
the time of requesting accreditation by FDA.
(3) For appropriate review of a particular class II device, FDA
will expect specialized education or experience to assure a technically
competent review. In addition, Accredited Persons will be expected to
consult national and/or international standards recognized by FDA or
review guidance.
2. Facilities
FDA expects to accredit persons that have the capability to
interface with FDA's electronic data systems, including FDA home page,
CDRH home page, and CDRH Facts-On-Demand. At a minimum, this would
include a computer system with a modem and an independent facsimile
machine. FDA will rely extensively on the use of FDA's electronic data
systems for timely public dissemination of guidance documents to
Accredited Persons.
3. Prevention of Conflicts of Interest
FDA expects Accredited Persons to 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 accredit a person, FDA will consider
whether the person has established, documented, and executed policies
and procedures to prevent any individual or organizational conflict of
interest, including conflicts of contractors or individual contract
employees.
4. Training
Accredited Persons must certify in their application that they will
have designated employees attend FDA training for Accredited Persons.
FDA plans to provide such training on a periodic basis for persons
newly accredited. FDA encourages applicants who wish to begin
submitting reviews on November 21, 1998, to apply at least 60 days
before the scheduled October 14 through 16, 1998 training session. FDA
will not accept 510(k) reviews and recommendations from Accredited
Persons that have failed to have at least one designated employee
attend a training session for Accredited Persons.
C. Safeguards
The Third Party Review Program established by FDAMA includes
safeguards to maintain a high level of quality in 510(k)'s reviewed by
Accredited Persons and to minimize risk to public health. To ensure
that persons accredited under section 523 of the act will continue to
meet the standards of accreditation, the statute requires FDA to: (1)
Make onsite visits on a periodic basis to each Accredited Person to
audit the performance of such person, and (2) take such additional
[[Page 28390]]
measures as the agency determines to be appropriate.
In addition, the statute permits FDA to suspend or withdraw
accreditation of any person accredited under section 523 of the act,
after providing notice and an opportunity for an informal hearing, when
such person is substantially not in compliance with the requirements of
this section or poses a threat to public health or fails to act in a
manner consistent with the purposes of this section.
The act also has been amended to establish a new prohibited act
section to protect the integrity of the Accredited Person Program
established by section 523 of the act. It is a prohibited act under new
section 301(y)(1) of the act (21 U.S.C. 331(y)(1)) for an Accredited
Person to:
(1) Submit a report that is false or misleading in any material
respect;
(2) Disclose confidential information or trade secrets without the
express written consent of the person who submitted such information or
secrets to the Accredited Person; or
(3) Receive a bribe in any form or do a corrupt act associated with
a responsibility delegated to the Accredited Person under the act.
FDA also is requiring applicants who wish to become an Accredited
Person to establish policies designed to identify, prevent, and ensure
reporting to FDA, of instances of forum shopping by submitters of
510(k)'s. Submitters of 510(k)'s who consult with more than one party
in order to find the Accredited Person who is most likely to recommend
clearance of the 510(k) will undermine the independence and integrity
of the Accredited Person Review Program. FDA, therefore, expects
Accredited Persons to ensure that the submitters of the 510(k)'s they
are reviewing have not previously presented the submission to another
Accredited Person.
It is not feasible to identify or state categorically all of the
criteria for evaluating whether a submitter has forum shopped. However,
if FDA determines that a submitter has obtained reviews of the same
510(k) from more than one Accredited Person, there will be a
presumption of forum shopping and FDA may refuse to provide special
processing of a submitter's 510(k) unless the submitter can explain to
FDA's satisfaction why the circumstances do not indicate forum
shopping.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(k) 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.
IV. Paperwork Reduction Act of 1995
This voluntary third party review program contains information
collection provisions which are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). FDA has submitted this proposed collection of
information to OMB and has requested emergency processing under section
3507(j) of the Paperwork Reduction Act of 1995 and 5 CFR 1320.13. The
information is essential to the agency's mission and is needed
immediately to meet the statutory deadline for implementation of the
voluntary third party review program as required by FDAMA. The use of
normal clearance procedures would be likely to result in the prevention
or disruption of this collection of information. The title,
description, and respondent description of the information collection
provisions are shown below with an estimate of the annual recordkeeping
and periodic reporting burden. Included in the estimate is the time for
reviewing instructions, gathering and maintaining the data needed, and
completing and reviewing each 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 FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Medical Devices; FDAMA Third-Party Review.
Description: Section 210 of FDAMA establishes a new section 523 of
the act, directing FDA to accredit persons in the private sector to
review certain premarket applications and notifications. As with the
third party pilot program previously conducted by FDA, participation in
this third party review program by accredited persons is entirely
voluntary. A third party wishing to participate will submit a request
for accreditation. Accredited third party reviewers will have the
ability to review a manufacturer's 510(k) submission for selected
devices. After reviewing a submission, the reviewer will forward a copy
of the 510(k) submission, along with the reviewer's documented review
and recommendation, to FDA. Third party reviewers should maintain
records of their 510(k) reviews and a copy of the 510(k) for a
reasonable period of time. This information collection will allow FDA
to implement the Accredited Person review program established by FDAMA
and improve the efficiency of 510(k) review for low to moderate-risk
devices.
Description of Respondents: Businesses or other for-profit
organizations.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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No. of
Item No. of Responses per Total Annual Hours per Total Hours
Respondents Respondents Responses Respondents
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Request for accreditation 40 1 40 24 960
510(k) reviews conducted by
accredited 3rd parties 35 4 140 40 5,600
Total hours 6,560
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 28391]]
Table 2.--Estimated Annual Recordkeeping Burden1
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Annual
Item No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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510(k) reviews 35 4 140 60 8,400
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The burdens are explained as follows:
1. Reporting
a. Requests for accreditation: Under the agency's third-party
review pilot program, the agency received 37 applications for
recognition as third party reviewers, of which the agency recognized 7.
Under this expanded program, the agency anticipates that it will not
see a significant increase in the number of applicants. Therefore, the
agency is estimating that it will receive 40 applications. The agency
anticipates that it will accredit 35 of the applicants to conduct
third-party reviews.
b. 510(k) reviews conducted by accredited third-parties: In 18
months under the Third Party Review Pilot Program, FDA received only 22
510(k)'s that requested and were eligible for review by third parties.
Because the new program is not as limited in time, and is expanded in
scope, the agency anticipates that the number of 510(k)'s submitted for
third-party review will increase. The agency anticipates that it will
receive approximately 140 third party review submissions annually,
i.e., approximately 4 annual reviews per each of the estimated 35
accredited reviewers.
2. Recordkeeping
Third party reviewers are required to keep records of their review
of each submission. The agency anticipates approximately 140 annual
submissions of 510(k)'s for third party review.
Prior to the implementation of the program, FDA will publish in the
Federal Register a notice of OMB's decision to approve, modify, or
disapprove the information collection provisions. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
Dated: May 19, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-13799 Filed 5-20-98; 8:45 am]
BILLING CODE 4160-01-F
