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LINKS
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 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) Medical Device Reporting MEDWATCH 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)
PARTNERS
BBL (Bay Bioanalytical Laboratory) HTD Biosystems Vitalea Science PTRL West Coeur Scientific
OTHER
ISO (International Organization for Standardization) TSS (Technical Safety Services) Nutek
