Medical Device Establishment Registration - Information and Instructions, May 1987

摘要

The purpose of the Medical Device Establishment Regulation document is to provide information and instructions for completion of the Initial Registration of Medical Device Establishment Form (FDA 2891). Owners or operations of all device establishments, not exempt from the registration requirements, that engage in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use are required to register. The term 'device' includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under Section 351 of the Public Health Service Act (42 U.S.C. 262). Such owners or operators are required to register their principal place of business and all such establishments whether the output of such establishments enter interstate commerce. Information on who is not required to register is also included in the publication.