Guidance for Industry and FDA Staff. Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions

摘要

This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs) (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance follows the substance, spirit, and meaning of the ASR regulations already in place.