Which regulation pertains to the establishment registration and device listing for manufacturers?

The regulation that pertains to establishment registration and device listing for manufacturers is found in 21 CFR 807. This regulation establishes the requirements for device registration, which is necessary for manufacturers and initial importers of medical devices to submit their information to the FDA. The primary purpose of this regulation is to facilitate the FDA’s ability to monitor medical devices and track the manufacturers who produce them, ensuring that only safe and effective devices are available to the public.

Under 21 CFR 807, manufacturers must register their establishment with the FDA and list the devices they intend to market. This process includes providing details about the manufacturing facility, the types of devices produced, and information on any changes in the manufacturing operations or device modifications. Accurate and timely registration and listing are crucial for compliance with federal regulations and for maintaining the ability to market devices within the United States.

In contrast, other regulations mentioned do not specifically address establishment registration and device listing. For instance, 21 CFR 814 deals with premarket approval applications for certain medical devices, focusing more on the safety and effectiveness of these devices before they can be approved for marketing. 21 CFR parts 100s and 700s cover general labeling and cosmetic products, respectively, and do not pertain to the registration and listing