Directory of FDA, ISO, EU and CE Agencies: http://www.fda.gov, www.iso.org, IEC, CFSAN, ONPLDS, CDER, nccam.nih.gov, hhs.gov, ana-jana.org, ul.com, fda.gov/cdrh, NelsonLabs, dhs.ca.gov/fdb, cdfa, cirm, California (CA) and US Federal Government

FDA/ISO Regulatory Affairs Consultants

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www.fda.gov, www.iso.org, IEC, FDA-CFSAN, FDA-ONPLDS, FDA-CDER, FDA-CDRH, www.nih.gov, www.hhs.gov, NIH, HHS

UL, CSA, IEC and FDA regulations for medical devices and pharmaceuticals/drugs, Regulatory affairs consultants, FDA / ISO / EU / CE regulations, registration and certification

California Government Agencies and United States Federal Government Agencies

ul.com, fda.gov/cdrh, nelsonlabs, dhs.ca.gov/fdb, cdfa, cirm, California (CA) and US Federal Government

FDA, ISO, EU and CE Agencies: www.fda.gov, iso.org, IEC, CFSAN, ONPLDS, CDER, nccam.nih.gov, hhs.gov, ana-jana.org

ISO and FDA medical regulatory consultants for Southern California CA (San Diego, Orange County and Los Angeles-LA) and Northern California CA (San Jose and San Francisco)

AREAS OF EXPERTISE

FDA 510k

PMA • NDA

Quality•GMP•ISO•CE/EU MDD

Supplements•Botanicals

Lab Testing•Clinical Trials

Risk Management

International

State Regulations

Business Start-ups

USEFUL INDUSTRY LINKS

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

United States/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