AAMI (Association for the Advancement of Medical Instrumentation)
CDRH
CDRH Databases
CDRH Referral List
Code of Federal Regulations (CFR)
21 CFR
FDA Consumer Information
Device Advice
Export of Medical Devices
Federal Food, Drug, and Cosmetic Act
Federal Science Website
FDA (Federal Drug Administration)
FDA’s Small Business Assistance
Global Harmonization
Good Guidance Practices (GGP)
Medical Device Reporting Problems
Medical Device Exemptions
Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
Premarket Approval
Premarket Notification (510(k))
Establishment Registration and U.S. Agent
Medical Device Listing
CDRH Standards Program
Third Party Review Program
USP (U.S. Pharmacopeia)
PHARMACEUTICAL AND BIOTECHNOLOGY
ICH Guidelines
PDA (Parenteral Drug Association)
USP (U.S. Pharmacopeia)
PROFESSIONAL AND TRADE ASSOCIATIONS
American Society for Microbiology (ASM)
Association for the Advancement of Medical Instrumentation (AAMI)
American College of Toxicology (ACT)
Society of Toxicology (SOT)
International Society for Pharmaceutical Engineering (ISPE)
ISO (International Organization for Standardization)
TSS (Technical Safety Services)