[Federal Register: October 4, 2002 (Volume 67, Number 193)]
[Notices]
[Page 62252-62253]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc02-60]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
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