美国FDA指导原则 Device Labeling Guidance #G91-1 (blue book memo).docxVIP

Device Labeling Guidance #G91-1 (blue book memo) Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email \o Print this page Print This guidance was written prior to the February 27, 1997 implementation of FDAs Good Guidance Practices, GGPs. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGPs. General Program Memorandum #G91-1 Date: March 8, 1991 From: Director, Office of Device Evaluation (HFZ-400) Subject: Device Labeling Guidance To: ODE Review Staff Purpose The primary purpose of this memorandum is to formalize guidance to ODE reviewers concerning their review of labeling in device marketing submissionsr especially premarket approval applications (PhAs). This guidance is intended to ensure the adequacy of, and consistency in, device labeling information. The guidance is also intended for industry use in preparing device labeling. Background General labeling requirements for medical devices have been established in 21 CFR Part 801. Detailed and specific labeling requirements for in vitro diagnostic products were promulgated under 21 CFR 809.10. Neither of these, however, provide specific definitions or explanations of some significant terms such as warnings, precautions, contraindications and adverse reactions. The lack of definitions for such terms leads to misunderstandings and disagreements between PMA applicants and the ODE review staff. Because labeling content is a key factor in the CDRH determination of whether there is reasonable assurance that a device is safe and effective for its intended user such disputes have unnecessarily prolonged PMA review times. Scope and Application of th