[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Notices]
[Pages 13936-13938]
From the Federal Register Online via the Government Publishing 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
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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
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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]
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