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FDA Links and Guidance Documents:

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

Small Business Resources
www.fda.gov/about-fda/doing-business-fda/small-business-resources

FDA Forms
www.fda.gov/about-fda/reports-manuals-forms/forms

Code of Federal Regulations (Title 21 – Food and Drugs: Parts 1 to 1499)
www.ecfr.gov/current/title-21

—  Medical Devices Section  —

Center for Devices and Radiological Health
www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health

Device Advice
www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

Device Registration and Listing
www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

Device Import/Export Issues
www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/importing-and-exporting-medical-devices/

Biologics – Center for Biologics Evaluation and Research
www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber

Drugs – Center for Drugs Evaluation and Research
www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder

Combination Products
www.fda.gov/combination-products

FDA Form 483 FAQ
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions

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

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