§801.109. Prescription devices. — Inbound Citations

A device subject to § 801.109 shall be exempt at the time of delivery to the ultimate purchaser or user from section 502(f)(1) of the act if it is delivered by a licensed practitioner in the course of his professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order.

A device subject to § 801.109 shall be exempt from section 502(f)(1) of this act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.

(b) The exemptions conferred by §§ 801.119, 801.122, and 801.125 shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502(f)(1) of the act. If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by § 801.109.

(7) § 801.109; and

(6) A prescription hearing aid that is not labeled as required under this section and § 801.109 is misbranded under sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and Cosmetic Act.

(b) Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.

(6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and

(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;

(b) Class II (special controls) prescription use in accordance with § 801.109 of this chapter; conformance with recognized standards of biocompatibility, electrical safety, and sterility; clinical and analytical performance testing, and proper labeling.

(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and

(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;

(b) Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(F) The symbol statement “Rx only” or “℞ only” may be used as provided under § 801.109(b)(1).

(7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.

(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.

(2) The labeling required under § 801.109(c) of this chapter must include:

(iv) Detailed instructions for use, including the information provided in the training program used to meet the requirements of paragraph (b)(1)(iv) of this section.

(v) A warning that the images and data acquired using the device are to be interpreted only by qualified medical professionals.

(vii) A statement on upholding the As Low As Reasonably Achievable (ALARA) principle with a discussion on the associated device controls/options.

(2) The labeling required under § 801.109(c) of this chapter must include:

(i) An explanation of the device and the mechanism of operation;

(ii) Validated methods and instructions for reprocessing of any reusable components;

(iii) Disposal instructions; and