[Federal Register Volume 67, Number 193 (Friday, October 4, 2002)]
[Notices]
[Pages 62252-62253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 01D-0202


Medical Devices: The Least Burdensome Provisions of the FDA 
Modernization Act of 1997; Concept and Principles; 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 the final guidance entitled ``The Least Burdensome 
Provisions of the FDA Modernization Act of 1997: Concept and 
Principles.'' This final guidance discusses the agency's interpretation 
of the least burdensome provisions of the Federal Food, Drug, and 
Cosmetic Act (the act).

DATES: Submit written or electronic comments on the guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``The Least Burdensome 
Provisions of the FDA Modernization Act of 1997: Concept and 
Principles'' to the Division of Small Manufacturers, International and 
Consumer 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. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Joanne R. Less, Center for Devices and 
Radiological Health (HFZ-403), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850 301-594-1190; or Leonard Wilson, 
Center for Biologics Evaluation and Research (HFM-25), Food and Drug 
Administration, Bldg. 29B, rm. 5G07, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    A central purpose of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) was to ensure the timely availability of safe and 
effective new products that would benefit the American public. While 
Congress wanted to reduce unnecessary burdens associated with the 
premarket clearance and approval processes, Congress did not lower the 
statutory thresholds for substantial equivalence or reasonable 
assurance of safety and effectiveness. To help achieve this goal, 
Congress added section 513(i)(1)(D) and (a)(3)(D)(ii) to the act (21 
U.S.C. 360c(i))(l)(D) and (a)(3)(D)(ii). Specifically, section 
513(i)(1)(D) states:

    Whenever the Secretary requests information to demonstrate that 
devices with differing technological characteristics are 
substantially equivalent, the Secretary shall only request 
information that is necessary to making substantial equivalence 
determinations. In making such request, the Secretary shall consider 
the least burdensome means of demonstrating substantial equivalence 
and request information accordingly.
Section 513(a)(3)(D)(ii) states that:
    Any clinical data, including one or more well-controlled 
investigations, specified in writing by the Secretary for 
demonstrating a reasonable assurance of device effectiveness shall 
be specified as a result of a determination by the Secretary that 
such data are necessary to establish device effectiveness. The 
Secretary shall consider, in consultation with the applicant, the 
least burdensome appropriate means of evaluating device 
effectiveness that would have a reasonable likelihood of resulting 
in approval.
    These two paragraphs of section 513 of the law contain what are 
commonly referred to as the ``least burdensome provisions'' of the act. 
CDRH worked with its stakeholders to develop an interpretation of the 
least burdensome provisions that would accurately capture Congress' 
intent and that could be implemented consistently by the agency and 
industry. As presented in this final guidance, the agency considers the 
least burdensome concept to be one that could affect almost all 
premarket regulatory activities, including presubmission meetings with 
industry, premarket submissions, and the development of guidance 
documents and regulations.
    The level 1 draft was made available in the Federal Register of May 
3, 2001 (66 FR 22241), and the 90-day comment period for the draft 
ended on August 1, 2001. While almost all of the comments strongly 
supported the guidance and encouraged full implementation of it as soon 
as possible, several comments included recommendations for the agency. 
Specifically, it was recommended that FDA develop a training program 
for its staff on the least burdensome approach as well as ways to 
assess both the agency's success in implementing the principles and 
industry's satisfaction with FDA's incorporation of them into its daily 
activities. The agency agrees with these comments, and its responses to 
them are discussed in the ``Foreword'' of the guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the least burdensome provisions of the 
act. 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 and 
regulations.

III. Electronic Access

    In order to receive ``The Least Burdensome Provisions of the FDA 
Modernization Act of 1997; Concept and Principles'' via your fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. Press 1 to enter the system. At 
the second voice prompt press 1 to order a document. Enter the document 
number (1332) followed by the pound sign ([numsign]). Follow the 
remaining voice prompts to complete your request.

[[Page 62253]]

    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 Internet access. 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.

IV. Comments

    Interested persons may, at any time, submit written comments 
regarding this guidance to 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. Submit two copies of any 
comments, 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. In many cases, comments may be submitted 
electronically at http://www.fda.gov/opacom/backgrounders/voice.html. 
The guidance document and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25195 Filed 10-3-02; 8:45 am]
BILLING CODE 4160-01-S