ABSTRACT
In the United States, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices and radiation-emitting products. The FDA is a science-based regulatory and public health agency. Federal laws establish the legal framework within which FDA operates. Based on the laws set forth in the Federal Food, Drug, and Cosmetic Act and other federal laws, the FDA develops regulations. Guidance documents facilitate the regulatory process by providing more information on the interpretation of medical device regulations and laws. CDRH guidance pertaining to convenience kits includes documents such as "Convenience Kits Interim Regulatory Guidance" and "Sterilized Convenience Kits for Clinical and Surgical Use." If the preceding information and resources are not sufficient to ascertain whether a product is a device, or its associated classification, CDRH has additional resources available to the public.
