AAMI (Association for the Advancement of Medical Instrumentation) CDRH CDRH Databases CDRH Referral List Index of CDRH Web Documents Code of Federal Regulations (CFR) 21 CFR Consumer Information/CDRH Device Advice DSMICA Staff Directory Electronic Products Radiation Control Export of Medical Devices Federal Food, Drug, and Cosmetic Act Federal Science Website FDA (Federal Drug Administration) FDA’s Centers Small Business Contacts Global Harmonization Good Guidance Practices (GGP) International Program Medical Device Reporting MEDWATCH Medical Device Exemptions Medical Device User Fee and Modernization Act of 2002 (MDUFMA) Premarket Approval Premarket Notification (510(k)) 510(k) Paradigm Establishment Registration and U.S. Agent Medical Device Listing Reuse of Single Use Devices CDRH Standards Program The Medical Device R&D Handbook Third Party Review Program Third Party Inspection Programs USP (U.S. Pharmacopeia)
ICH Guidelines PDA (Parenteral Drug Association) USP (U.S. Pharmacopeia)
American Society for Microbiology (ASM) Association for the Advancement of Medical Instrumentation (AAMI) Parentheral Drug Association (PDAA) Society of Industrial Microbiology (SMI) American College of Toxicology (ACT) Society of Toxicology (SOT) International Society for Pharmaceutical Engineering (ISPE)
BBL (Bay Bioanalytical Laboratory) HTD Biosystems Vitalea Science PTRL West Coeur Scientific
ISO (International Organization for Standartization) TSS (Technical Safety Services) Nutek
