Meaning of intended uses.

§ 801.4 Meaning of intended uses. Link to an amendment published at 82 FR 2217, Jan. 9, 2017. This amendment was delayed until Mar. 21, 2017, at 82 FR 9501, Feb. 7, 2017. This amendment was further delayed until Mar. 19, 2018, at 82 FR 14319, Mar. 20, 2017. This amendment delayed indefinitely at 83 FR 11639, Mar. 16, 2018. The words intended uses or words of similar import in §§  801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. [86 FR 41401, Aug. 2, 2021] Effective Date Note: At 82 FR 2217, Jan. 9, 2017, § 801.4 was revised, effective Feb. 8, 2017. At 82 FR 9501, Feb. 7, 2017, this amendment was delayed until Mar. 21, 2017. At 82 FR 14319, Mar. 20, 2017, this amendment was further delayed until Mar. 19, 2018. At 83 FR 11639, Mar. 16, 2018 this amendment was delayed indefinitely. For the convenience of the user, the revised text is set forth as follows: § 801.4 Meaning of intended uses. The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the device, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. And if the totality of the evidence establishes that a manufacturer objectively intends that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the device from the requirements of section 502(f)(1), to provide for such device adequate labeling that accords with such other intended uses.