Pub. L. 107-250, tit. III, sec. 301

IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.

EnactedYear: 2002Length: 155 wordsOfficial source
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES. (a) In General.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: “(u) If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary determines that compliance with the requirement is not feasible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device.”. (b) Effective Date.—The amendment made by subsection (a)takes effect 18 months after the date of the enactment of this Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.
Pub. L. 107-250, tit. III, sec. 301: IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES. | Justis AI