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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.
DATES: This rule is effective September 1, 2021.
ADDRESSES: For access to the docket to read background documents or comments received, go to https
www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the Search box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Kelley Nduom, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
209930002, 3017965400, kelley.nduom@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
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I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Meaning of Certain Terms in This Preamble III. Background A. Introduction and History of This Rulemaking B. Summary of Comments to the Proposed Rule IV. Legal Authority V. Comments on the Proposed Rule and FDA
Responses A. Introduction B. Comments and Responses Regarding Statutory and Regulatory Authority C. Comments and Responses Regarding the Design or Composition of an Article D. Comments and Responses Regarding the First Amendment E. Comments and Responses Regarding the Fifth Amendment F. Comments and Responses Regarding Definitions G. Comments and Responses Regarding Safe Harbors H. Comments and Responses Regarding Examples I. Comments on Codified Text and FDA
Responses J. Comments Recommending That FDA
Expand the Scope of This Rulemaking
VI. Effective Date VII. Economic Analysis of Impacts A. Introduction and Summary B. Final Economic Analysis of Impacts C. Final Small Entity Analysis VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995
X. Federalism XI. Consultation and Coordination With Indian Tribal Governments XII. References
I. Executive Summary A. Purpose of the Final Rule FDA is taking this action to amend its existing regulations 201.128 and 801.4 21 CFR 201.128 and 801.4
describing the types of evidence relevant to determining a products intended uses under the FD&C Act, the PHS Act, and FDAs implementing regulations. The amended regulations better reflect the Agencys current practices in evaluating whether a product is intended for use as a drug or device, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action withdraws the portions of the final rule issued on January 9, 2017 82 FR 2193, that never became effective, and it finalizes amendments to the intended use regulations for medical products that provide more clarity and direction to regulated industry and other stakeholders regarding the types of evidence relevant to determining a products intended uses.
B. Summary of the Major Provisions of the Final Rule FDA is finalizing amendments to its intended use regulations for medical products 201.128 and 801.4 to better reflect the Agencys current practices in evaluating whether a product is intended for use as a drug or device, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use.
Several comments on the proposed rule raised legal concerns. Some commenters argued that FDA should construe its statutory and regulatory authorities more narrowly, and some asserted that the proposed rule violates
the First and Fifth Amendments. These and similar arguments have been raised in comments received during earlier stages of this rulemaking as well as in other rulemaking proceedings, petitions, and litigation involving intended use issues. A number of other comments raised questions about the rules applicability to certain medical devices, such as devices that are exempt from premarket notification 510k requirements. These comments also criticized the inclusion of language in the regulation clarifying that the design or composition of an article may be relevant to determining its intended use.
The final rule remains largely unchanged from the proposed rule. In response to comments received, we have modified the codified language of the intended use regulation for medical devices to clarify its applicability to devices that are approved, cleared, granted marketing authorization, or exempted from premarket notification.
That is the only change from the codified language in the proposed rule.
C. Legal Authority Among the provisions that provide authority for this final rule are sections 201, 403r, 503g, and 701a of the FD&C Act 21 U.S.C. 321, 343r, 353g, 371a; section 5b3 of the Orphan Drug Act 21 U.S.C. 360eeb3; and sections 215, 301, 351i and j, and 361
of the PHS Act 42 U.S.C. 216, 241, 262i and j, and 264.
D. Costs and Benefits The benefit of this final rule is the added clarity and certainty for firms and stakeholders regarding the evidence relevant to establishing whether a product is intended for use as a drug or device, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. We do not have evidence that the final rule will impose costs on currently marketed products.
II. Meaning of Certain Terms in This Preamble As used in this rulemaking, the following terms have the meanings noted below.

Term
Meaning
A medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification.

This term refers to a medical product that may be legally introduced into interstate commerce for at least one use under the FD&C Act or the PHS Act as a result of having satisfied applicable premarket statutory and regulatory requirements.

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