Useful FDA 510(k) Links:
- United States Food and Drug Agency 510(k) Database Search
- US FDA 510k Overview
- Where to submit an US FDA 510(k)
- US FDA, 510(k) FAQs
- How to prepare Special 510k Submissions/Notifications
US FDA Links for Applied Nutrition, Dietary Supplements and Alternative Medicines
- United States Food and Drug Agency 510(k) Database Search
- FDA-CFSAN – Center for Food Safety and Applied Nutrition
- FDA-Division of Dietary Supplements
- FDA-Guidance Documents for Botanical Drug Products
US/Federal Department of Health and Human Services (HHS) and National Institutes of Health (NIH)
- NIH National Center for Complementary and Alternative Medicine (NCCAM)
- NIH OAM Office of Alternative Medicine
- NIH Office of Dietary Supplements (ODS)
- Dietary Supplements
Natural Products Associations
- ANA-American Nutraceutical Association
- NPA-Natural Products Association
- ABC-American Botanical Council
- DIA-Home: Drug Information Association
FDA, IEC, ASTM, UL and CSA Compliance Testing
- Underwriters Laboratories (UL)
- TUV America – International Testing Lab
- ASTM
- FDA – Electromagnetic Compatibility and Wireless Medical Devices
- Nelson Laboratories (Utah)
- Intertek-Etlsemko
- Namso (OH)
International Standards and Healthcare/Life Science Organizations
- ISO International Organization for Standardization
- IEC International Electrotechnical
Commission(Commission Electrotechnique Internationale) - WHO World Health Organization
- WTO World Trade Organization
- EU: European Commission/Enterprise and Industry
- FDA’s list of International Organizations and Foreign Government Agencies
- FDA Import and Export of Investigational Devices
- TUV (Accredited for Quality Management Systems/Product Certification
- GHTF – Global Harmonization Task Force
- People’s Republic of China (PRC) Ministry of Health (Chinese Language)
- India Central Drug Standards Organization
- Japan’s Pharmaceuticals and Medical Devices Evaluation Center
Useful Risk Management Information
- FDA Risk Management Initiative
- Review of FDA Guidance on Risk Management (Genetic Engineering and Biotechnology News)
- ISO 14971:2007/2006 Standards for Medical Device Hazards
State Agencies
California State Agencies (Sacramento, CA)
- California Department of Health Services (CDHS)
- CDHS Food and Drug Branch and Division of Food, Drug and Radiation Safety
- CDHS Licensing and Certification Program
- California Office of Administrative Law (OAL)
- California department of Food and Agriculture (CDFA)
- California Institute for Regenerative Medicine (CIRM)
- Medical Board of California (MBC)
- State of Oregon Public Health Division
- Washington State Department of Health
- Arizona Department of Health Services
