[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Pages 28388-28391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13799]



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.


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.


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 
    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 
    (b) Limit work to that for which competence and capacity are 
    (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; 
    (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 
     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.); 
     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 
     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 
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 
    (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 

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 
    Description of Respondents: Businesses or other for-profit 
    FDA estimates the burden of this collection of information as 

                                  Table 1.--Estimated Annual Reporting Burden1                                  
                                                      No. of                                                    
              Item                    No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondents      Responses      Respondents                 
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       
\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                                
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
510(k) reviews                         35               4             140              60           8,400       
\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]