Voglio sapere a riguardo di…

41386

Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
V. Comments on the Proposed Rule and FDA Responses
khammond on DSKJM1Z7X2PROD with RULES

A. Introduction We received approximately 15 comment submissions on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues.
We describe and respond to the comments in sections B through J of this section. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comments value or importance or the order in which comments were received.
In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received several general comments expressing support for or opposition to the rule.
These comments express broad policy views and do not address specific points related to this rulemaking. Therefore, these general comments do not require a response. To the extent that comments expressing opposition to the rule requested that we refrain from finalizing the rule, we decline to do so. In general, comments outside the scope of this rulemaking have not been addressed here. Summaries of the remaining comments, as well as FDAs responses, are included in this document.
B. Comments and Responses Regarding Statutory and Regulatory Authority Comment 1 One comment asserted that under the relevant statutes, legislative history, and case law, evidence of intended use is limited to promotional claims that have been made in the marketplace. The comment argued that the NPRM was wrong in stating that evidence of intended use can be derived from any relevant source, including circumstances surrounding distribution. Other comments also encouraged the Agency to focus primarily or only on promotional claims.
Response We disagree. Nothing in the statute requires the narrow scope that the comment suggested. Although the first comment mentioned above loosely refers to the statutory and regulatory regime as support for its preferred interpretation, it does not cite any statutory language that dictates an
VerDate Sep<11>2014

16:00 Jul 30, 2021

Jkt 253001

exclusively claims-based approach to intended use. As four justices of the Supreme Court recognized in rejecting the argument that the statute limits evidence of intended use to promotional claims: The FD&C Act . . . does not use the word claimed; it uses the word intended FDA v. Brown &
Williamson Tobacco Corp., 529 U.S.
120, 170 2000 dissenting opinion the majority declined to resolve the issue, id. at 13132. The fact that intended use can be established through promotional claims does not preclude the possibility that other evidence may be relevant as well.
Nor does the comment cite any legislative history that supports an exclusively claims-based approach to intended use. Indeed, the legislative history supports reliance on evidence of use by healthcare practitioners and consumers as relevant to intended use.
The House Report on the Medical Device Amendments of 1976 states that the Secretary may consider . . . use of a product in determining whether or not it is a device see H.R. Rep. 853, 94th Cong., 2d Sess. 14 1976, reprinted in An Analytical Legislative History of the Medical Device Amendments of 1976, Appendix III Daniel F. OKeefe, Jr. and Robert A. Spiegel, eds. 1976.
Similarly, the legislative history of the 1938 Act states expressly that the use to which the product is to be put will determine the category into which it will fall see S. Rep. No. 361, 74th Cong., 1st Sess. 4 1935, reprinted in 3 Legislative History 660, 663.
Nor does the language of the existing regulation support the commenters position. Nowhere does the regulation state that evidence of intended use is limited to statements or claims published to the marketplace see United States v. Vascular Solutions, Inc., 181 F. Supp. 3d 342, 347 W.D.
Tex. 2016. Indeed, the existing regulations specifically state that evidence of intended use includes circumstances surrounding the distribution of the article and circumstances that the article . . . is offered or used for a purpose for which it is neither labeled or advertised. This language was included when the regulation was first codified in 1952 see 17 FR 6818, 6820 1952 Ref. 1.
Furthermore, the case law does not resolve the matter in favor of the position advanced by the commenter.
Courts have repeatedly held that intended use is determined by looking to any relevant evidence, including statements and circumstances surrounding the manufacture and distribution of a medical product see, e.g., United States v. Article of 216

PO 00000

Frm 00006

Fmt 4700

Sfmt 4700

Cartoned Bottles, Sudden Change, 409 F.2d 734, 739 2d Cir. 1969 It is well settled that the intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising and any other relevant source. citations omitted; V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 1st Cir. 1957
observing that a court is free to look to all relevant sources in order to ascertain what is the intended use of a drug. As explained by one court:
Whether a products intended use makes it a device depends, in part, on the manufacturers objective intent in promoting and selling the product. All of the circumstances surrounding the promotion and sale of the product constitute the intent. It is not enough for the manufacturer to merely say that he or she did not intend to sell a particular product as a device. Rather, the actual circumstances surrounding the products sale, such as the identity of actual customers and their use of the product and labeling claims, determine the intended use of the product as a device under the Act United States v.
789 Cases, More or Less, of Latex Surgeons Gloves, 799 F. Supp. 1275, 1285 D. Puerto Rico 1992 internal citations omitted.
Courts have rejected the commenters proposition that evidence of intended use is limited to a manufacturers public claims concerning a device or drug see Natl Nutritional Foods Assn v.
Matthews, 557 F.2d 325, 334 2d Cir.
1977 In determining whether an article is a drug because of an intended therapeutic use, the FDA is not bound by the manufacturers subjective claims of intent but can find actual therapeutic intent on the basis of objective evidence.
Such intent also may be derived or inferred from labeling, promotional material, advertising, and any other relevant source. internal citation and quotations omitted; United States v.
Travia, 180 F. Supp. 2d 115, 119 D.D.C.
2001 Labeling is not exclusive evidence of the sellers intent. Rather, . . . it is well established that the intended use of a product, within the meaning of the FD&C Act, is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source . . . even consumer intent could be relevant, so long as it was pertinent to demonstrating the sellers intent . . . If the governments allegations are true, the sellers did not need to label or advertise their product, as the environment provided the necessary information between buyer and seller. In this context, therefore, the
E:FRFM02AUR1.SGM

02AUR1