[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Notices]
[Pages 13936-13938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-5611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0331]


Medical Devices; Implementation of Third Party Programs Under the 
FDA Modernization Act of 1997; Final Guidance for Staff, Industry and 
Third Parties; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revision to the guidance document entitled ``Guidance 
for Staff, Industry and Third Parties: Implementation of Third Party 
Programs Under the FDA Modernization Act of 1997.'' The revised 
guidance supersedes the October 30, 1998, guidance. FDA has amended the 
October 30, 1998, guidance to include criteria for the review of 
additional moderate risk (class II) devices by accredited persons under 
the Federal Food, Drug, and Cosmetic Act (the act). The revised 
guidance will assist those who are interested in participating in the 
expanded program, which is now in effect.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance entitled ``Implementation of Third Party Programs Under 
the FDA Modernization Act of 1997; Final Guidance for Staff, Industry 
and Third Parties'' to the Division of Small Manufacturers Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
concerning this guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Comments should be identified with the docket number found in 
brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: John F. Stigi, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 1, 1996, FDA began a voluntary Third Party Review Pilot 
Program for selected medical device premarket notifications 
(``510(k)'s''). The purpose of the pilot program was to: (1) Provide 
manufacturers of eligible devices an alternative 510(k) 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. Under the program, all class I devices 
that were not exempt from 510(k) at that time and 30 class II devices 
were eligible for third party review.
    The Food and Drug Administration Modernization Act of 1997 (FDAMA) 
was signed into law by former President Clinton on November 21, 1997. 
Section 210 of FDAMA essentially codified and expanded the Third Party 
Review Pilot Program by establishing section 523 of the act (21 U.S.C. 
360m). Section 523 of the act directs FDA to accredit third

[[Page 13937]]

parties (accredited persons) in the private sector to conduct the 
initial review of 510(k)'s for low-to-moderate risk devices and make 
recommendations to FDA regarding the initial classification of these 
devices under section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)). FDA 
published criteria in the Federal Register of May 22, 1998 (63 FR 
28388), to grant or deny accreditation to persons who request to review 
510(k)'s. In addition, FDA issued a list of devices that were eligible 
for review by accredited persons (May 20, 1998), which was updated in 
June 2000 to include additional class II devices for which device-
specific guidance exists. This list is available on the Internet at 
http//www.fda.gov/cdrh/thirdparty. FDA also issued a guidance document 
entitled ``Guidance for Staff, Industry and Third Parties: 
Implementation of Third Party Programs Under the FDA Modernization Act 
of 1997'' (October 30, 1998). On November 21, 1998, FDA began accepting 
reviews and recommendations from accredited persons. Concurrently, FDA 
terminated the Third Party Review Pilot Program that began on August 1, 
1996.
    Industry use of third parties has been low. In an effort to 
encourage greater use of the Accredited Persons Program, the agency 
announced in the Federal Register of July 18, 2000 (65 FR 44540), a 
proposal to initiate a pilot that would allow third parties to review a 
significantly greater number of devices (hereinafter referred to as the 
July 2000 notice). Accordingly, FDA issued a draft revision of the 
October 30, 1998, guidance document and made available a proposed list 
of additional devices that would be eligible under the pilot.
    The pilot would expand the device list by allowing, subject to 
certain specified conditions, third party review of class II devices 
for which device-specific guidance does not exist. Until now, device-
specific guidance has existed for each class II device that is eligible 
for third party review. The pilot program would also include devices 
for which there is an exemption from 510(k). That is, if a new version 
of an exempted device requires a 510(k) because it exceeds the 
limitations of the 510(k) exemption for that device (as described in 
FDA's device classification regulations), the device would be eligible 
for third party review. The pilot, together with the existing device 
list, would allow third party review of all class I and class II 
devices regulated by CDRH that the agency believes are not prohibited 
from such review under the statute. Section 523(a)(3)(A) of the act 
specifies that an accredited person may not review: (1) A class III 
device, (2) a class II device which is intended to be permanently 
implanted or life-supporting or life-sustaining, or (3) a class II 
device which requires clinical data in the report submitted under 
section 510(k). (Section 523 of the act sets limits on the number of 
class II devices that may be ineligible for accredited person review 
because clinical data are required.)
    As with the current Accredited Persons Program, the pilot would not 
include 510(k)'s that require multi-Center review (e.g., 510(k)'s for 
drug/device combination products) or devices for which the Center for 
Biologics Evaluation and Research has primary responsibility for 
review. FDA believes that the expanded number of devices resulting from 
the pilot and the existing program will be sufficient to satisfy the 
criteria in section 523(c) of the act that trigger a 4- or 5-year 
timeframe for the duration of the Accredited Persons Program.
    Both the draft revised guidance document and the July 2000 notice 
provided an opportunity for public comment, which closed September 1, 
2000. Based on the comments received, the following substantive changes 
have been incorporated into the final version of the revised guidance.
    1. Section II.B (Outline of the Accredited Persons Review Program--
Purpose and Nature of the Program) has been revised as follows:
     FDA has clarified that accredited persons should receive 
expanded accreditation in order to review devices in the pilot.
     The recommended conditions for participation in the pilot 
have been revised. The condition that an accredited person complete 
three successful 510(k) reviews under the third party program in order 
to participate in the pilot has been retained. However, the condition 
that at least one of the reviews be in the same or a similar medical 
specialty area as the pilot devices that the accredited person intends 
to review has been removed. Also, the condition that an accredited 
person contact the appropriate CDRH Office of Device Evaluation (ODE) 
Branch Chief (or designee) before initiating a review of a device under 
the pilot has been revised. The revised condition for prereview contact 
applies only if the accredited person has not previously reviewed this 
type of device, i.e., a prereview contact is expected for the 
accredited person's first review of a particular device type but not 
for subsequent reviews of the same device type.
     The stated purpose of the prereview contacts has been 
revised for consistency with the above changes. Also, FDA has clarified 
that an accredited person's summary of prereview contacts: (1) Should 
be submitted to ODE with the accredited person's 510(k) review, (2) 
does not require prior ODE review or concurrence, and (3) is intended 
to be a simple record of the contacts rather than an ``agreement'' or 
de facto guidance.
    2. Section II.B (Outline of the Accredited Persons Review Program--
Devices Eligible for Accredited Person Review) has been revised to 
state that FDA will monitor the pilot continuously and will conduct a 
review 24 months, rather than 12 months, after it begins.
    3. Section II.B (Outline of the Accredited Persons Review Program--
Identification of an Accredited Person) has been revised to remove 
language encouraging manufacturers to use multiple accredited persons. 
In this context, the language was interpreted as suggesting that 
manufacturers should not interact repeatedly with the same accredited 
person, which was not FDA's intent.
    FDA believes that the revised guidance will contribute to timely 
and consistent third party reviews of 510(k)'s for the expanded list of 
devices. Accredited persons who wish to expand their accreditation to 
include devices in the pilot should submit a request to FDA, as 
described in Section III of the revised guidance document.

II. Significance of Guidance

    This guidance represents the agency's current thinking on expanding 
the scope of the Accredited Persons Program to include all devices not 
excluded by statute. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
applicable statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (65 FR 56468, September 19, 
2000). This guidance document is issued as a Level 1 guidance 
consistent with FDA's GGP's regulation.

III. Electronic Access

    In order to receive ``Implementation of Third Party Programs Under 
the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, 
and Third Parties'' via your fax machine, call CDRH Facts-on-Demand 
(FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. At the first

[[Page 13938]]

voice prompt press 1 to access DSMA Facts, at second voice prompt press 
2, and then enter the document number (1160) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh ``Implementation of Third Party Programs Under the FDA 
Modernization Act of 1997; Final Guidance for Staff, Industry and Third 
Parties'' is available at http://www.fda.gov/cdrh/thirdparty.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the guidance at any time. 
Such comments will be considered when determining whether to amend the 
current guidance. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The guidance document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 26, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-5611 Filed 3-7-01; 8:45 am]
BILLING CODE 4160-01-F