[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Notices]
[Pages 44540-44542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0331]


Medical Devices; Draft Guidance for Staff, Industry, and Third 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft revision to the guidance entitled, ``Guidance 
for Staff, Industry and Third Parties: Implementation of Third Party 
Programs Under the FDA Modernization Act of 1997.'' FDA is proposing to 
amend this guidance to provide procedures for third party review of 
additional moderate risk (class II) devices under the FDA Modernization 
Act of 1997 (FDAMA) Accredited Persons Program. As described in this 
document and in the draft guidance, FDA intends to expand the list of 
devices eligible for third party review. The revised guidance would 
assist those who are interested in participating in the expanded 
program.

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in the preparation of the final document by 
September 1, 2000.

ADDRESSES: Submit written requests for single copies on a 3.5 inch 
diskette of the draft guidance entitled ``Guidance for Staff, Industry, 
and Third Parties: Implementation of Third Party Programs Under the FDA 
Modernization Act of 1997'' 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. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
guidance.
    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.

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. The purpose of the pilot program was to: (1) Provide 
manufacturers of eligible devices 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. Under the program, all class I devices that were 
not exempt from premarket notification (510(k)) at that time and 30 
class II devices were eligible for third party review. 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.
    FDAMA was signed into law by the President on November 21, 1997. 
Section 210 of FDAMA essentially codified and expanded the Third Party 
Review Pilot Program by establishing a new section 523 of the Federal 
Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360m). Section 210 of 
FDAMA directs FDA to accredit third parties (Accredited Persons) in the 
private sector to conduct the review of 510(k)'s for low-to-moderate 
risk devices and make recommendations to FDA regarding the initial 
classification under section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)). FDA established and published criteria in the Federal 
Register on May 22, 1998 (63 FR 28388) to accredit or deny 
accreditation to persons who request to review 510(k)'s. In addition, 
FDA issued a list of devices that are eligible for review by Accredited 
Persons (May 20, 1998) as well as 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). Copies of these documents can be found at http://www.fda.gov/cdrh/thirdparty. By November 21, 1998, FDA accredited 13 
organizations to review 510(k)'s, and the agency was prepared to begin 
accepting reviews and recommendations from Accredited Persons. 
Concurrently, FDA terminated the Third Party Review Pilot Program that 
began on August 1, 1996. In the first 17 months that the FDAMA third 
party program has been in effect, 28 companies have used third parties 
to review a total of 54 510(k) submissions. During that same period, 
nearly 2,000 510(k) submissions from approximately 800 companies were 
eligible for third party review. This approach has typically yielded 
rapid marketing clearance decisions. In fiscal year 1999, the average 
total elapsed time between a third party's receipt of a 510(k) 
submission and FDA's substantial equivalence determination was 57 days. 
The portion of this time that occurred between FDA's receipt of the 
third party's recommendation and FDA's determination averaged just 15 
days. In spite of these advantages, industry use of the third party 
approach has been low.
    In an effort to expand the use of the Accredited Persons Program, 
the agency is proposing to initiate a pilot that will allow third party 
review of a greatly expanded list of devices (see details below). 
Accordingly, FDA is issuing a draft revision of the guidance document 
entitled ``Guidance for Staff, Industry and Third Parties: 
Implementation of Third Party Programs Under the FDA Modernization Act 
of 1997'' as well as making available an expanded list of additional 
devices that will be eligible under the pilot. Copies of these 
documents can be found at http://www.fda.gov/cdrh/thirdparty. After FDA 
reviews comments and finalizes this guidance, it will supersede the 
October 30, 1998, guidance currently in effect.
    The May 20, 1998, list of devices eligible for review by Accredited 
Persons included 50 class I devices and 104 class II devices. FDA 
included all class I devices, not exempt from 510(k), because the 
agency determined that general guidance provided by CDRH is a 
sufficient basis for third party review of these relatively low risk 
products. However, FDA's decision to include class II devices was 
partly dependent on the existence of device specific guidance and/or 
FDA recognized standards. FDA is currently updating the May 20, 1998, 
list to reflect changes

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in device classification and to include additional Class II devices for 
which device specific guidance is now available.
    In addition to updating the May 20, 1998, list, the agency is now 
proposing to initiate a pilot that will expand the device list by 
allowing third party review of all class II devices regulated by the 
Center for Devices and Radiological Health (CDRH) that the agency 
believes are not prohibited from such review under the statute,\1\ 
regardless of whether device specific guidance is available for the 
device. The pilot program will also include devices for which there is 
a limited exemption from 510(k). If a new version of a device requires 
a 510(k) because the change exceeds the limitation, that device is 
eligible for third party review unless it can not be reviewed by a 
third party because of the statutory exclusions under section 523 of 
the act. As with the current Accredited Persons Program, the expansion 
pilot will not include 510(k)'s that require multi-Center review (e.g., 
510(k)'s for drug/device combination products) and devices for which 
the Center for Biologics Evaluation and Research has primary 
responsibility for review.
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    \1\ Section 523(a)(3)(A) of the act specifies that an Accredited 
Person may not review: (a) A class III device; (b) a class II device 
which is intended to be permanently implanted or life-supporting or 
life-sustaining; or (c) 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.)
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    Any 510(k) for a class II device for which clinical data are needed 
to make a determination of substantial equivalence will continue to be 
subject to initial and supervisory review by FDA and will not be 
processed by FDA under the special procedures for the Accredited 
Persons Program. The decision to require clinical data is a matter of 
judgment that is often dependent on the nature of any differences 
between the new device and the device to which it is being compared 
(e.g., an additional specific indication for use). Manufacturers and 
Accredited Persons 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.
    FDA expects the pilot program to encourage more widespread use of 
the third party program. Under the pilot program, FDA will accept 
reviews from Accredited Persons of devices for which there is no device 
specific guidance under the following circumstances. An Accredited 
Person may review a class II device that does not have device specific 
guidance if:
    (1) The Accredited Person has previously completed three successful 
510(k) reviews under the third party program. This should include at 
least one 510(k) review that was in the same or similar medical 
specialty area as the device the Accredited Person now intends to 
review. The prior 510(k) reviews can be for class II devices that have 
device specific guidance or for class I devices.
    (2) The Accredited Person contacts the appropriate CDRH Office of 
Device Evaluation (ODE) Branch Chief (or designee) before initiating a 
510(k) review for a class II device that does not have device specific 
guidance to confirm that the Accredited Person meets the criteria in 
paragraph 1 above and to identify pertinent issues and review criteria 
related to this type of device.
    (3) The Accredited Person prepares a summary documenting the 
discussions and submits the summary of those discussions to ODE.
    The discussion and summary would not be binding on the agency or 
the Accredited Person. The presubmission discussions and the creation 
of a record of those discussions will help FDA ensure the consistency 
and timeliness that can be provided by device specific guidances. In 
addition, the FDA may utilize such documentation to ensure consistency 
in its own interactions with different Accredited Persons and regular 
submitters. Moreover, the record of these discussions will help FDA 
determine whether there is a need to issue device specific guidance and 
could facilitate future development of those documents.
    The pilot will begin after FDA reviews comments and finalizes the 
guidance entitled ``Guidance for Staff, Industry and Third Parties: 
Implementation of Third Party Programs under the FDA Modernization Act 
of 1997.'' Existing Accredited Persons should refer to the guidance for 
procedures on how to expand the scope of their accreditation. In 
addition, persons seeking to become accredited under section 523 of the 
act also should refer to the procedures in this guidance.
    The agency intends to review the pilot program in 12 months after 
it begins to see if the number of third party 510(k)'s has increased 
significantly, if the timeliness of review is maintained, and to 
consider whether particular divisions within CDRH's Office of Device 
Evaluation are devoting disproportionate staff time to presubmission 
discussions with Accredited Persons. The agency reserves the option to 
stop or reevaluate the pilot at any time it determines that additional 
work load generated by third party consultations compromises FDA's 
ability to review other applications or the agency has reason to 
believe the quality of the reviews is significantly diminished by lack 
of device specific guidance.

II. Significance of Guidance

    This draft guidance represents the agency's current thinking on 
expanding the scope of the Accredited Persons Program to include class 
II devices not excluded by statute. It does not create nor 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 (62 FR 8961, February 27, 
1997). This guidance document is issued as a draft Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Guidance for Staff, Industry, and Third 
Parties: Implementation of Third Party Programs Under the FDA 
Modernization Act of 1997,'' 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 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 draft 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. ``Guidance

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for Staff, Industry and Third Parties: Implementation of Third Party 
Programs Under the FDA Modernization Act of 1997'' will be available at 
http://www.gov/cdrh/dsma/3rdptythirdparty.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
September 1, 2000. 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. A copy of the document and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: July 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-18083 Filed 7-17-00; 8:45 am]
BILLING CODE 4160-01-F