FDA RESOURCE TOOLS
 

QSIT (Quality System Inspection Technique) For Medical Devices

FDA-483s, Frequently Requested from FDA via Freedom of Information (FOI)

FDA’s Device Advice (Research tool on FDA’s website for basic information)

Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s

Search for FDA Guidance Documents

Import and Export Guidance Documents

Enforcement Reports showing all Recalls Monitored by FDA

The Regulatory Procedures Manual  - a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters

FDA CDRH (Center for Device & Radiological Health) Management Directory by Organization

Search the FDA Database

Search CFR (Code of Federal Regulations)

Inspection Reference Guides provided to FDA investigators and inspectors to assist them in their daily activities

FDA’s Compliance Program Manual: provides instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA

Warning Letters on FDA’s Website

Search for Federal Register Notices

 

additional RESOURCES:

The Document Center, where you can obtain almost any standard

ASQ Biomedical Division

Regulatory Affairs Professional Society (RAPS)

International Medical Device Regulators Forum

Association for the Advancement of Medical Instrumentation (AAMI)