[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Notices]
[Pages 47846-47847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2873]


Medical Devices; Draft Guidance on Evidence Models for the Least 
Burdensome Means to Market; 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availability of a draft guidance entitled ``Evidence Models for the 
Least Burdensome Means to Market.'' This draft guidance is intended to 
provide guidance to the medical device industry and FDA reviewers on 
implementing section 205 of the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). Section 205 requires FDA, in 
consultation with the product sponsor, to consider the ``least 
burdensome'' means that will allow appropriate premarket development 
and review of a product without unnecessary delays and expense to 
manufacturers. This draft guidance represents the agency's current 
thinking on implementing section 205 of FDAMA, and it is neither final 
nor is it in effect at this time.

DATES: Written comments concerning this draft guidance must be 
submitted by November 30, 1999.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the draft guidance entitled 
``Evidence Models for the Least Burdensome Means to Market'' 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 one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-443-8818. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Susan Alpert, Center for Devices and 
Radiological Health (HFZ-400), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2022.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Evidence Models for the Least Burdensome Means to Market.'' Section 
205 of FDAMA requires FDA, in consultation with the product sponsor, to 
consider the ``least burdensome'' means that will allow appropriate 
premarket development and review of a product without unnecessary 
delays and expense to manufacturers. This draft guidance is designed to 
help both the Center for Devices and Radiological Health (CDRH) 
reviewers and the medical device industry apply the new provisions of 
FDAMA. Through this draft guidance, CDRH intends to establish a general 
approach for applying the least burdensome provisions that will be 
applicable to any device application; this draft guidance does not 
attempt to establish specific clinical data requirements for any 
particular type of submission.
    The focus of this draft guidance is the application of the least 
burdensome provisions to clinical data requirements because the input 
from stakeholders has indicated that the regulated industry is most 
concerned with FDA's interpretation of these provisions with respect to 
clinical data.
    In addition, as this draft guidance was being developed, it became 
clear that it cannot easily be applied to in vitro diagnostic devices 
(IVD's) because of the unique clinical data needs associated with 
establishing IVD performance. The agency is soliciting comments on 
applying the least burdensome provisions to data requirements for 
IVD's.
    To foster a collaborative approach to the implementation of section 
205 of FDAMA, FDA's CDRH hosted a meeting with stakeholders on January 
4, 1999, to solicit comments and suggestions regarding the least 
burdensome approach to medical device development and evaluation. CDRH 
heard formal presentations at that meeting and also received written 
comments.
    This draft guidance has incorporated, in part, the written proposal 
dated March 11, 1999, from the ``Least Burdensome Industry Task Force'' 
convened by the Health Industry Manufacturers Association, comments 
from the January 4, 1999, stakeholders meeting, and other stakeholder 
communications.
    This draft guidance represents the agency's current thinking on 
implementing the ``least burdensome'' provisions of section 205 of 
FDAMA. 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 (62 FR 8961, February 27, 
1997). This draft guidance is issued as a level 1 guidance consistent 
with GGP's.

II. Electronic Access

    In order to receive the draft guidance document entitled ``Evidence 
Models for the Least Burdensome Means to Market'' via your fax machine, 
call the 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 DMSA Facts, at the second voice prompt press 2, and then enter 
the document number 1154 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 World Wide Web (WWW). CDRH maintains an entry on 
the WWW for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with access to the 
Web. Updated on a regular basis, the CDRH home page includes the draft 
guidance document entitled ``Evidence Models for the Least Burdensome 
Means to Market,'' 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''.

III. Comments

    Interested persons may, on or before November 30, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding this draft guidance. Two copies of any comments are to be 
submitted, except individuals may submit one copy. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. A copy of the draft guidance and received comments

[[Page 47847]]

are available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 25, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-22677 Filed 8-31-99; 8:45 am]
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