• Regulatory Consulting

  • Registration & Listing

  • Call 619-517-0673

FDA Links and Guidance Documents:

Food and Drug Administration (FDA)
www.fda.gov

Small Business Guide
www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm

FDA Forms
www.fda.gov/opacom/morechoices/fdaforms/fdaforms.html

Code of Federal Regulations
(CFR Title 21 – Food and Drugs: Parts 1 to 1499) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

—  Medical Devices Section  —

Center for Devices and Radiological Health
www.fda.gov/cdrh/

Device Advice
www.fda.gov/cdrh/devadvice/

Device Registration and Listing
www.fda.gov/cdrh/reglistpage.html

Device Import/Export Issues
www.fda.gov/cdrh/international/

Biologics-Center for Biologics Evaluation and Research
www.fda.gov/cber/index.html

Drugs- Center for Drugs Evaluation and Research
www.fda.gov/cder/index.html

Combination Products
www.fda.gov/oc/combination/

FDA Form 483 FAQ

www.fda.gov – Form 483 FAQ

German American Chamber of Commerce, California
www.gacca.com

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