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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations Term
Meaning
A medical use that is approved, cleared, granted marketing authorization, or exempted from premarket notification.

This term refers to an intended use included in the required labeling for an FDA-approved medical product, an intended use included in the indications for use statement for a device cleared or granted marketing authorization by FDA, or an intended use of a device that falls within an exemption from premarket notification.
This term refers to manufacturers, packers, and distributors of FDAregulated products and all their representatives, including both individuals and corporate entities.
This term refers to individuals such as physicians, veterinarians, dentists, physician assistants, nurse practitioners, pharmacists, or registered nurses who are licensed or otherwise authorized by the State to prescribe, order, administer, or use medical products in a professional capacity.
This term refers to drugs and devices, including human biological products.
This term refers to medical products that are not approved, cleared, granted marketing authorization, or exempted from premarket notification as that phrase is described above by FDA for any medical use, and which must be approved, cleared, granted marketing authorization, or exempted from premarket notification to be legally marketed for such use. This term also includes products that are marketed for non-medical uses, such as dietary supplements, conventional foods, and cosmetics.
This term refers to an intended use that is not included in the required labeling of an FDA-approved medical product, an intended use that is not included in the indications for use statement for a device cleared or granted marketing authorization by FDA, or an intended use of a device that does not fall within an exemption from premarket notification.

Firms
Healthcare providers

Medical products
Products unapproved for any medical use

Unapproved use of a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification.

III. Background A. Introduction and History of This Rulemaking
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The Agency issued a proposed rule in 2015 and a final rule in 2017 revising the language of its medical product intended use regulations, with the intent to conform them to the Agencys current practice in applying the regulations see final rule, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products;
Amendments to Regulations Regarding Intended Uses 82 FR 2193, January 9, 2017. These amendments did not reflect a change in FDAs approach regarding types of evidence of intended use for drugs and devices. However, after receiving a petition that requested the Agency reconsider these amendments, FDA delayed the effective date of the 2017 final rule and reopened the docket to invite public comment. A
number of comments submitted during the reopening raised questions and, on March 16, 2018 83 FR 11639, FDA
delayed the effective date of the intended use amendments until further notice to allow further consideration of the substantive issues raised in the comments received. After considering the issues raised in the petition and comments submitted during the reopening, FDA issued a notice of proposed rulemaking in September 2020

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85 FR 59718, September 23, 2020, the NPRM to withdraw the portions of the final rule issued on January 9, 2017, that never became effective and to propose a new rule to provide more clarity regarding the types of evidence that are relevant in determining a products intended uses.
B. Summary of Comments to the Proposed Rule Approximately 15 comments on the proposed rule were submitted to the docket. These comments were submitted by various industry trade organizations, consumer advocacy groups, and individuals. Several comments raised legal concerns with the proposed rule, including arguments to the effect that the rule violates the First and Fifth Amendments. Other comments raised questions and concerns about the rules applicability to certain medical devices, such as devices that are 510k-exempt. These comments also generally objected to the inclusion of language in the regulation clarifying that the design or composition of an article may be relevant to determining its intended use.
IV. Legal Authority Among the statutory provisions that provide authority for this final rule are sections 201, 403r, 503g, and 701a of the FD&C Act, section 5b3 of the Orphan Drug Act, and section 351i of
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the PHS Act. Section 201 of the FD&C
Act defines drug subsection g1, device subsection h, food subsection f, dietary supplement subsection ff, cosmetic subsection i, and tobacco product subsection rr1; section 5b3 of the Orphan Drug Act defines medical food; and section 503g1 of the FD&C Act provides that combination products are those that constitute a combination of a drug, device, or biological product.
Section 351i of the PHS Act defines biological products, and section 351j of the PHS Act provides that the requirements of the FD&C Act apply to biological products. Section 403r of the FD&C Act establishes the requirements under which certain labeling claims about uses of conventional foods and dietary supplements to reduce the risk of a disease or affect the structure or function of the human body are not evidence of intended use as a drug.
Under section 701a of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act. FDA regulates the manufacture, sale, and distribution of drugs, devices, combination products, tobacco products, foods including dietary supplements, and cosmetics under the authority of the FD&C Act.

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