Links
Here are some useful links related to FMDIC and medical device regulatory issues:
- FDA’s Center for Devices and Radiological Health (CDRH)
- FDA CDRH Device Advice
- FDA CDRH Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
- FDA CDRH Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
- CDRH Learn
- FDA CDRH Mailing Lists
- CDRH Recognized Consensus Standards Database
- FDA CDRH Recent Additions
- Title 21 of the Code of Federal Regulations
- Federal Register
- Certificates, Licenses and Permits
- Drugs and Medical Devices Division
- Medical Device Distributor and Manufacturer Rules & Regulations
Industry Associations
- Association for the Advancement of Medical Instrumentation (AAMI)
- Advanced Medical Technology Association (AdvaMed)
- American College of Clinical Engineering (ACCE)
- American Society for Quality (ASQ)
- ASQ Biomedical Division (ASQ Biomed)
- BioAustin
- Contact Lens Manufacturers Association (CLMA)
- Food & Drug Law Institute (FDLI)
- Medical Device Manufacturers Association (MDMA)
- Regulatory Affairs Professionals Society (RAPS)
Regulatory Associations
- Association of Food and Drug Officials (AFDO)
- Mid-Continental Association of Food and Drug Officials (MCAFDO)
