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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
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the communication relates to a patient population outside the approved patient population reflected in the FDArequired labeling, the communication may not be considered consistent with the approved labeling. The Par brief cited in the comment confirms that a manufacturers communication of information regarding an approved use to a physician whose patients do not fall within the products approved population would not by itself establish a new intended use, but may be relevant together with other evidence in establishing the manufacturers intent to distribute the product for an unapproved use Ref. 3 at 1718.
Comment 26 Several comments requested modification to or clarification of the examples provided in section V.C. of the preamble to the proposed rule.
Response We decline to make the requested modifications to the examples. These examples were provided to illustrate evidence that, standing alone, would not be determinative of intended use, and they remain illustrative of that point.
Although one comment suggested that the examples caused further confusion, most commenters indicated that the examples were helpful and encouraged FDA to offer additional examples. We continue to believe the examples provided in the preamble to the NPRM
are helpful, and we are providing additional examples below. The list of examples in the proposed rule is not intended to be comprehensive or restrictive. Each scenario described in the preamble is fact-specific, and, under other circumstances or in other contexts, similar material may be evaluated differently.
Comment 27 Several comments requested that FDA describe the intended use framework from the device industry perspective and provide additional device-specific examples.
Response The examples FDA
provided in the preamble to the proposed rule were provided for illustrative purposes only and were not intended to be comprehensive or restrictive. In our responses to comments 7, 8, and 9 in this final rule preamble, we have provided additional examples of types of evidence 3 related 3 As described in the preamble to the proposed rule, these types of evidence include express claims and representations; implied claims; product characteristics and design; and the circumstances of the products sale or distribution see 85 FR 59718
at 59725. In fulfilling its mission to protect the public health, FDA will evaluate the individual and unique circumstances of each case in determining a products intended use. In some cases, a single piece of evidence may be dispositive of a products
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to product design and composition that may be relevant when determining a medical devices intended use. Those examples describe evidence that may be relevant, but is not necessarily determinative, to establishing intended use.
To further clarify this regulation as it applies to devices, we are providing here additional device-specific examples of types of evidence that may be relevant, but are not necessarily determinative, in establishing intended use. As with the examples in the preamble to the proposed rule, the following examples are fact-specific and are provided for illustrative purposes only.
Marketing a medical device with a name that implies a use to affect a particular organ or system of the body.
Example: CardioCalm.
Designing a non-vascular stent with a coating clinically known to change calcification of blood vessels.
Marketing a device that uses ultrasonic waves as a therapeutic massager, despite the fact that ultrasonic waves do not physically massage tissue but rather affect the underlying tissue through a sonic mechanism.
I. Comments on Codified Text and FDA
Responses Comment 28 In the NPRM, FDA
proposed to amend 201.128 and 801.4 to provide that a firm would not be regarded as intending an unapproved new use for an approved drug or for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firms knowledge that such drug or device was being prescribed or used by healthcare providers for such use.
One commenter argued that FDA should delete solely from the regulations on intended use because this phrasing suggests that a firms knowledge of unapproved use could be used in combination with other factors to determine the intended use of a product. Another commenter suggested that FDA should replace solely with a term that would clarify that such knowledge would be relevant only if such use is widespread and if a companys promotional activities are a primary reason for this widespread offlabel use. This commenter also maintained that the final rule should be clear that only activities that are, at their core, promotional should be relevant for determining intended use.
Response FDA disagrees with these comments. The use of the word solely intended use. In others, several elements combined may establish a products intended use.

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in 201.128 and 801.4 is intended to convey that FDA does not intend to consider a firms knowledge that a healthcare provider has used or prescribed the firms medical product that has been approved, cleared, granted marketing authorization, or is exempt from 510k for an unapproved use, by itself, as sufficient to establish intended use. The removal of the word solely from the regulation and the suggestion that FDA consider only activities that are fundamentally promotional in determining intended use would be inconsistent with the Agencys longstanding position that determining a products intended use is a factspecific inquiry and that FDA may consider all relevant sources of evidence. These sources of evidence may include a firms knowledge that a healthcare provider has used or prescribed the firms medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification for an unapproved use, and may include activities that are not strictly promotional in nature. In short, direct promotion of the use is not necessary to establish intended use.
Comment 29 One comment asked FDA to change article to device throughout 801.4.
Response FDA disagrees with this suggestion. The use of the term article in 201.128 and 801.4 is consistent with the use of that term in section 201
of the FD&C Act.
Comment 30 A comment suggested deleting the phrase or used from the fourth sentence of 801.4, asserting that a healthcare providers use is not under the control of the firm.
Response FDA disagrees with the comments suggestion because, although the healthcare providers use is not under the firms control, what may be relevant to intended use is the firms knowledge that the article is being used by the healthcare provider. As discussed above, both legislative history and the case law support reliance on actual use by healthcare providers as relevant to intended use. See, e.g., United States v.
An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 7th Cir.
1984; United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F.
Supp. 1159, 1165 D. Utah 1989; United States v. Device Labeled Cameron Spitler Amblyo-Syntonizer, 261 F.
Supp. 243, 245 D. Neb. 1966; H.R. Rep.
No. 853, 94th Cong., 2d Sess. 14 1976.
However, a firms knowledge that healthcare providers are prescribing or using its product that has been approved, cleared, granted marketing authorization, or is 510k-exempt for an
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