FDA Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
Title:
FDA Guidance for Industry and FDA Staff
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071269.pdf
Document Type:
Guidance for Industr
Content:
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.