FDA Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
Title:
FDA Quality System Information
for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
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/
Document Type:
Guidance
Content:
This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the QS information required in premarket submissions1.
This guidance replaces “Guidance for Preparation