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Food and Drug Administration Resources

:: GENERAL RESOURCE LINKS ::

 

Affirmation of Compliance Codes

 

FDA Forms

 

Import for Export

 

FDA for Industry

 

Import Alerts / Import Alert by Number / Import Alerts Subscription

 

Industry Specific Email Addresses

Industry.Foods@fda.gov

Industry.Cosmetics@fda.gov

Industry.Devices@fda.gov

Industry.DietarySupplements@fda.gov

Industry.Radiological@fda.gov

Industry.AnimalVeterinary@fda.gov

Industry.Drugs@fda.gov

Industry.Tobacco@fda.gov

 

ITAC Support :: itacssupport@fda.hhs.gov

 

Export Certificates

 

Reconditioning

 

Regulatory Procedures Manual

 

 

 

:: DRUG RESOURCE LINKS :: 

cderimportsexports@fda.hhs.gov

 

CDER Small Business & Industry Assistance

 

eDRLs Team :: edrls@fda.hhs.gov

 

Registration & Listing

 

Drug Approval Databases

 

 

 

:: FOOD RESOURCE LINKS ::

 

Color Additives

 

LACF Registration 

 

LACF Team :: LACF@fda.hhs.gov

 

Labeling & Nutrition Guidance Documents & Regulatory Information // Food Labeling Guide

 

Fish and Fishery Products Hazards and Controls Guidance // Seafood HACCP

 

 

:: MEDICAL DEVICE RESOURCE LINKS ::

CDRH Import Export Staff :: cdrhocimports@fda.hhs.gov

CDRH Small Business Contact :: dsmica@fda.hhs.gov

 

Classifying Your Medical Device

 

Convenience Kits

 

Premarket Notification 510(k)

 

Device Advice: Comprehensive Regulatory Assistance

 

Letter to Industry about Import Entry Review Process, March 2011

 

Letter to Industry about Import Entry Review Process, September 2011

 

How to Study and Market Your Device (PMA)

 

Who Must Register & List

 

 

:: LENSES RESOURCE LINKS ::

 

Certificate of Impact Resistance

 

Guidance for Industry Impacts Resistant Lenses Q & A

 

How to Register & List

 

Importing & Exporting Devices

 

Medical Device Databases

 

 

:: RADIATION-EMITTING PRODUCT RESOURCE LINKS ::

 

Form 2877: Declaration for Imported Electronic Products Subject to Radiation Control Standards

 

 List of Radiating Emitting Devices

 

Radiating Emitting Product Codes

 

Radiating Emitting Products Subject to Performance Standards

 

Who Must Register & List: