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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
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cleared medical uses do not include such legally marketed devices and asked FDA to modify these terms to include 510k-exempt devices. One comment also suggested that FDA recognize how its review of drug and device labeling differ.
Response FDA agrees with adding language to 801.4 to clarify that the regulation applies to devices that are exempt from premarket notification and devices that are granted marketing authorization through De Novo classification. We are adding the phrase granted marketing authorization, or exempt from premarket notification to the fourth sentence of 801.4 to make this clarification.
FDA declines to compare FDAs review of drug and device labeling because such comparison is beyond the scope of this rulemaking.
Comment 22 Some comments suggested defining the terms unapproved new use for an approved or cleared and unapproved use of an approved product in the codified.
Another comment asserted that these terms were not consistently used throughout the preamble.
Response We have included related terms and phrases in the definitions section of the preamble above to help clarify our use of these and similar phrases. We do not believe that it is necessary to include these definitions in the codified language.
Comment 23 Some comments requested FDA expressly include laboratorians in the definition of healthcare providers.
Response The term healthcare provider includes a non-exhaustive list of individuals who are licensed or otherwise authorized by the State to prescribe, order, administer, or use medical products in a professional capacity. In some cases, this may include such licensed or otherwise State-authorized individuals with certain roles in a laboratory.
G. Comments and Responses Regarding Safe Harbors Comment 24 A number of comments suggested modifications to FDA policies that the comments sometimes refer to as safe harbors for certain kinds of medical product communications. Some comments suggested the establishment of a safe harbor for scientific exchange, whereby scientific exchange would be excluded from determinations of intended use. Other comments suggested the creation of safe harbors for other types of communications, including discussions with healthcare providers about investigational uses, discussions held in the course of
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providing training or demonstrations to healthcare providers, market research about unapproved uses, and communications related to the collection of postmarket data. Another comment urged that FDA codify in binding regulations its policies regarding manufacturer communication of scientific and medical information, noting that guidance documents are not binding on enforcement authorities including the Department of Justice.
Response FDA welcomes and will continue to consider these comments related to safe harbors. However, the recommendations made in these comments go beyond the scope of this rulemaking, which is to conform 201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices, 80 FR 57756 2015. This rule, as proposed and as finalized, does not reflect a change in FDAs policies and practices regarding the types of firm communications that ordinarily would not, on their own, establish a new intended use. Expanding the scope of this rule to codify FDAs acknowledged safe harbors or to acknowledge additional safe harbors, as suggested in these comments, might warrant reproposing the rule to solicit additional input, unduly delaying the Agencys clarification of its regulations on intended use. Therefore, while FDA will continue to consider the issues raised by these comments, the Agency declines the present suggestions to modify its acknowledged safe harbors or codify them in the intended use regulation.
With regard to the suggestion that the Agency establish a safe harbor for scientific exchange, whereby scientific exchange would be excluded from determinations of intended use: the Agency notes that if all scientific exchange were excluded from determinations of intended use, companies might have an incentive to create and promote new intended uses for marketed products based on incomplete or otherwise flawed data.
That outcome would not serve the public health. At the same time, FDA
recognizes the importance of scientific exchange, including information regarding unapproved uses of products that healthcare providers may choose to take into account when making professional judgments regarding the use of medical products that are approved, cleared, granted marketing authorization, or exempted from premarket notification. Balancing these public health considerations, some of which are in tension with each other, is a complex and important task. FDA
believes this rulemaking, the purpose of which is to finalize amendments to the
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intended use regulations, is not the appropriate forum to resolve separate questions relating to scientific exchange.
As noted in the NPRM, FDA has issued several guidance documents that describe circumstances in which the Agency does not intend to object to a firms medical product communications or to view such communications as evidence of a new intended use. See 85
FR 59718 at 59723 n.7. This final rule does not disturb any of FDAs acknowledged safe harbors, including those that encompass various types of scientific exchange. In addition, as discussed in the preamble to the proposed rule, a firms knowledge of off-label use plus safe-harbored communication would not, without more, be determinative of a new intended use. See 85 FR 59718 at 59725.
H. Comments and Responses Regarding Examples Comment 25 One comment requests that FDA clarify, consistent with the Governments brief filed in Par Pharmaceutical Inc. v. United States, 1:11-cv-01820 D.D.C., that the example of repeated proactive detailing in the preamble to the proposed rule would not create a new intended use if the firms communications with the healthcare professionals are consistent with the approved labeling.
Response FDA declines the suggestion because FDA does not believe the proposed clarification is warranted. As explained in the preamble, the revisions to the intended use regulations do not reflect a change in FDAs policies and practices, including as articulated in various guidance documents, regarding the types of firm communications that ordinarily would not, on their own, establish the firms intent that a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification be used for an unapproved use see 85
FR 59718 at 59723. The NPRM
references guidance documents including FDA Guidance for Industry, Medical Product Communications That Are Consistent With the FDA-Required LabelingQuestions and Answers, June 2018 see id. Ref. 5. As explained in that guidance, FDA does not intend to rely exclusively on a firms communication of information that is consistent with a medical products FDA-required labeling to establish a new intended use. The example in the NPRM, however, describes a circumstance involving a patient population that does not fall within the products approved population see 85
FR 59718 at 59725 and, to the extent
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