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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
unapproved use would not, by itself, automatically trigger an obligation to provide labeling for that unapproved use.
Comment 31 One comment suggested that FDA explain how 801.4
applies to modifications of 510kcleared devices.
Response FDA declines to adopt this suggestion because it is beyond the scope of this rulemaking.
Comment 32 One comment stated that section 513i1E of the FD&C Act 21 U.S.C. 360ci1E constrains how FDA responds to an intended use not reflected in device labeling when reviewing a 510k and that FDA
cannot require that the company obtain clearance or approval of another potential unapproved use. The comment also suggested FDA
disassociate intended use regulations for devices from drugs and add a reference to section 513i1E of the FD&C Act in the codified text of 801.4.
Response FDAs application of section 513i1E of the FD&C Act is beyond the scope of this rulemaking.

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J. Comments Recommending That FDA
Expand the Scope of This Rulemaking Comment 33 A number of comments urged FDA to expand this rulemaking beyond the scope of the proposed rule.
For example, one comment urged FDA
to complete its long-promised comprehensive review of regulations to assess alignment with constitutional and statutory requirements. Another comment proposed that FDA adopt a regulatory approach to manufacturer speech consistent with the Principles on Responsible Sharing of Truthful and NonMisleading Information About Medicines with Health Care Professionals and Payers developed by Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization.
Response Although FDA welcomes the submission of ideas regarding a broader list of suggested policy changes, we decline to adopt the suggestions in these comments because they are beyond the scope of this rulemaking.
Expanding the scope of this rule as suggested in these comments would potentially delay FDAs clarification of its regulations on intended use. FDA has been engaged in a continuing review of regulations and policies regarding communications with healthcare providers and payors and other similar entities with knowledge and expertise in healthcare economic analysis regarding medical products, and has taken other initiatives as part of that effort.

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Comment 34 One comment contended that the regulatory requirements for premarket approval and authorization are too burdensome so that it is unreasonable to require that manufacturers conduct studies and submit applications for every intended use.
Response This comment also raises issues that are different from and beyond the scope of this rulemaking. To the extent this comment is suggesting that the best way to address complex questions concerning premarket authorization is through limiting the scope of intended use, we disagree that this is an appropriate tool.
Comment 35 One comment requested that FDA acknowledge that healthcare providers may prescribe and use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their patients and that manufacturers are not required to confirm the nature of a healthcare providers planned use for an approved medical product before distributing such product to the healthcare provider.
Response Healthcare providers prescribe or use medical products that are approved, cleared, granted marketing authorization, or exempted from premarket notification for unapproved uses based on their medical judgment regarding any potential benefits and risks of the unapproved use for their individual patients.4 In these limited circumstances, FDAs longstanding position is that the Agency does not consider a firms knowledge that a healthcare provider has used or prescribed its medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification for an unapproved use, by itself, as sufficient to establish the intended use element of a prohibited act based on failing to meet applicable premarket requirements for that use or failing to provide adequate directions for use.5
4 FDA generally does not seek to interfere with the exercise of the professional judgment of healthcare providers in prescribing or using, for unapproved uses for individual patients, most legally marketed medical products. This longstanding position has been codified with respect to devices see 21 U.S.C. 396. Although FDA generally does not seek to interfere with the exercise of the professional judgment of veterinarians, certain unapproved uses of drugs in animals are not permitted see section 512a4 and 5 of the FD&C Act 21 U.S.C. 360ba4 and 5
and 21 CFR part 530 and result in the drug being deemed unsafe and therefore adulterated under sections 512 and 501a5 21 U.S.C. 351a5 of the FD&C Act.
5 See 21 U.S.C. 331d, 351f, 352f1, 355a.
The position described in the text does not apply to products that are not already legally marketed as
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VI. Effective Date This final rule will become effective 30 days after the date of its publication in the Federal Register.
VII. Economic Analysis of Impacts A. Introduction and Summary 1. Introduction We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act 5 U.S.C. 601612, and the Unfunded Mandates Reform Act of 1995 Pub. L. 1044. Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity. This final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We cannot predict how many companies may revise labeling, advertising, or other materials, or otherwise modify their behavior, following issuance of this rule. However, this rule would merely clarify, but not change, the types of evidence relevant to determining manufacturers intended use of products. Because the rule would not extend FDAs authority to additional products or impose any additional requirements on currently regulated products, we expect the rule will impose negligible costs, if any. As a result, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 section 202a requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal medical products for at least one use. Similarly, nothing in this regulation or preamble is intended to impact the application of 21 U.S.C. 333e, which, subject to limited exceptions, penalizes anyone who knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of disease or other recognized medical conditions, where such use has been authorized by the Secretary of Health and Human Services under section 505 and pursuant to the order of a physician. Further, Congress or the Agency could promulgate other provisions regarding specific products or classes of medical products that recognize knowledge as sufficient evidence of a particular element of a prohibited act.

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