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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations function of the body and therefore meets the device definition in section 201h of the FD&C Act 21 U.S.C.
321h. The addition of the phrase design or composition to the codified reflects FDAs longstanding and current policy that these are relevant to intended use.
As discussed in the preamble to the NPRM, an example of a situation where design features have been found relevant to intended use include the design of a stent to be specifically sized for a use that is different from the purported use see 85 FR 59718 at 59725. Another example can be found in United States v. Caputo, 517 F.3d 935
7th Cir. 2008, where the Seventh Circuit upheld a conviction for misbranding under the FD&C Act where design features were part of the evidence of intended use. There, the district court recited evidence of the differences in design between two versions of the device that necessitated separate premarket review applications:
The larger sterilizer had different design and engineering characteristics: a six cubic foot chamber; a 5% peracetic acid mixture; different temperature, pressure, and gas flow rate; and a single, as opposed to multiple, use of the sterilant United States v. Caputo, 456
F. Supp. 2d 970, 973 N.D. Ill. 2006, affd in relevant part, 517 F.3d 935 7th Cir. 2008. As another example, a factfinder might consider, as evidence of a new intended use, a spacer that the manufacturer claims can be used to elute one liquid, but is in fact designed with holes that are sized to elute a more viscous substance that contains a different active ingredient.
Another example where composition has been found relevant to intended use is United States v. Undetermined Quantities . . .Pets Smellfree, 22 F.3d 235 10th Cir. 1994. In that case, the Government had seized and sought to condemn Pets Smellfree as an adulterated and misbranded drug. The product was promoted as an animal food additive to reduce pet odor when ingested. In determining that the product was a drug, the Tenth Circuit relied heavily on expert testimony about the physiological effects of a pharmacologically active ingredient, chlortetracycline, in reducing the level of bacteria in the animals digestive systems and oral cavities see id. at 240.
Other examples include United States v.
Zeyid, 1:14-cr-0197, First Superseding Indictment N.D. Ga. June 24, 2014 see Ref. 2, where imported products labeled as tea, coffee, and beauty products contained active ingredients that were the same as those used in prescription drugs; FDA Warning Letter
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to HelloCig Electronic Technology Co., Ltd. Ref. 9, where undeclared active pharmaceutical ingredient was considered relevant to intended use;
and FDA Warning Letter to INZ
Distributors Ref. 13, where presence of analogue of an erectile dysfunction drug was considered relevant to intended use.
Comment 8 Some comments suggested that consideration of design or composition of the article as a type of evidence of intended use may inhibit technological advancements and discourage manufacturers from developing products that, based on their design, may be used for multiple uses.
Response FDA disagrees with these comments. We do not believe that considering a products design or composition to be relevant to the intended use of a product impedes technological advancements or discourages product development. As stated above, the relevance of a products design and composition to intended use is a part of FDAs longstanding policy and has not hindered such improvements. For example, during premarket review of software, FDA may not always review a software device function that is included in the design but has been locked out, because it is not part of that specific premarket submission by the firm. If, however, the firm wants to unlock the software device function in the future, it must first obtain any necessary premarket clearance, marketing authorization or approval for the product with that function.
Comment 9 One comment suggested that FDA should not seek enforcement after a product is approved, cleared, or granted marketing authorization solely based on that products design or characteristics, and another comment suggested that FDA should not assert a new intended use based solely on such features.
Response FDA applies applicable premarket and postmarket statutory and regulatory requirements to determine whether a product is legally marketed.
FDA examines all relevant evidence in assessing compliance with such requirements. As previously noted, FDA
may consider a products design or composition as one type of evidence relevant to the products intended use.
D. Comments and Responses Regarding the First Amendment Comment 10 One comment stated that because the rule identifies speech as potentially relevant to establishing intended use, and such speech may be truthful, the rule is suspect under the First Amendment. The comment
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requested that FDA add specific statements to the codified language to address these concerns. Other comments similarly stated that the proposal does not adequately take into account the limitations on FDAs authority to regulate truthful and nonmisleading speech.
Response We disagree that the rule is vulnerable under the First Amendment. First, as noted in the preamble to the NPRM, we do not believe this rulemaking implicates the First Amendment. The intended use regulations describe evidence that may be relevant to establishing intended use;
they do not in themselves directly regulate speech 85 FR 59718 at 59723.
Indeed, the changes to the codified language proposed and finalized in this rulemaking do not directly involve speech: Whether, and to what extent, a factfinder may rely on product design, product composition, and knowledge as evidence of intended use, is not itself a First Amendment question, because speech will not typically be involved in such evidence. See 82 FR 2193 at 2207.
Second, in the regulatory regime under the FD&C Act and the PHS Act, intended use helps determine the marketing status for products that are potentially subject to those Acts, which products Congress has directed FDA to regulate in the interest of the public health. Part of the regulatory regime for medical products involves, for example, the review of appropriate labeling in the context of premarket review and postmarket regulatory surveillance. The categorical exclusion of all truthful speech from regulatory review would undermine FDAs ability to promote and protect the public health through premarket review of medical products, including review of proposed labeling, and postmarket regulatory surveillance and actions.
For example, the Government prosecuted a clinic operator under the FD&C Act for injecting liquid silicone into the body to augment tissues such as the buttocks or breasts Refs. 14 and 15.
Silicone when used for industrial purposes would not fall within FDAs jurisdiction. However, in this case, evidence that helped establish the intended use of the products included testimony of victims about the claims made to them by the defendant that the product would enhance the size of their buttocks. Those claims may have been truthful in the sense that they revealed one effect of the product. However, the injection of liquid silicone into the body for tissue augmentation can result in serious adverse health consequences, including hardening of tissue at the injection site, embolization, and even
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