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Medical Devices: The Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept and Principles; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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 (#). Follow the remaining voice prompts to complete your request.

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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.

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Dated: September 27, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 02-25195 Filed 10-3-02; 8:45 am]

BILLING CODE 4160-01-S