For Industry
Frequently Asked Questions
Below are frequently asked questions and the associated answers sorted by topic area. Please rate the answers to the questions in order to help us to better meet your needs.
Animal & Veterinary
Drug Review
Overview
What is the role of the Center for Veterinary Medicine (CVM) in FDA and what does CVM regulate?
Marketing Products Regulated by CVM
What is the process for a new animal drugs application?
What are the labeling requirements that my business must meet?
Reporting
What is the process for Veterinary Adverse Event Reporting for Manufacturers?
Cosmetics
Does FDA approve cosmetics before they go on the market?
Does FDA pre-approve cosmetic product labeling?
Are cosmetic companies required to register with FDA?
Are all "personal care products" regulated as cosmetics?
Do I need to label my products with expiration dates?
How can I tell if my product is a cosmetic, a drug, or both?
Where can I find more FDA resources for the cosmetics industry?
Drugs
Drug Review
What information is provided to sponsors during the human drug product application review process?
Drug Approval
How can I better understand Patents and Exclusivity?
I wish to market an OTC drug product – where do I start?
How do I go about getting a drug approved?
I am a small business owner, where can I find information specific for me?
Import and Export
What must I do to import a human drug product that has been approved by the FDA into the US?
What must I do to export a human drug product from the US?
Guidances
Drug Registration and Listing
If I am required to register my drug facility and list my drug product, how do I proceed?
Food
Allergen Labeling
What is the Food Allergen Labeling and Consumer Protection Act of 2004?
What is a “major food allergen?”
Juice HACCP Regulation
Where can I find more information on conducting a hazard analysis?
How many critical control points (CCPs) should there be in a HACCP plan?
The Reportable Food Registry
What is the Reportable Food Registry?
What foods are covered by the Reportable Food Registry?
How has FDA improved the RFR since the portal opened in September 2009?
Is help available for food facilities that have questions about the RFR?
Food Safety Modernization Act (FSMA)
View FSMA Frequently Asked Questions
Medical Devices
Medical Device Review Process
Overview of Medical Device Regulation
How can I find out if my product is regulated by CDRH?
How to Market a Medical Device
What protocol needs to be followed to get a medical device approved?
What are the steps to prepare and submit a Premarket Notification (510(k)) application?
How can I find out how FDA will classify my device?
Does my device need to be labeled? What information should be included in the labeling?
Importing and Exporting Devices
What must I do to import medical devices and radiation-emitting products into the US?
What must I do to export medical devices and radiation-emitting products from the US?
Radiation-Emitting Products
Overview of Radiation-Emitting Products
How can I find out if my product is regulated by CDRH?
What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products?
What products are regulated as electronic products that emit radiation?
Performance Standards
How do I know if an FDA performance standard applies to my product?
Importation of Electronic Products
What must I do to import radiation-emitting products into the US?
Getting More Information
Tobacco
General Information
I am a small business owner, where can I find information specific for me?
Why is FDA regulating cigarettes and smokeless tobacco products?
Youth Access and Advertising Regulations
Who is covered, or impacted, by the Youth Access and Advertising regulations?
How will FDA enforce the Youth Access and Advertising regulations?
What tobacco products are covered by the Youth Access and Advertising regulations?
How do the Youth Access and Advertising regulations affect retailers who sell only tobacco products?
Cigarette Health Warnings
Why is FDA requiring graphic health warnings for cigarette packages and advertisements?
What are the requirements for placement of the graphic health warnings?
What are the requirements for displaying the graphic health warnings?
Who must comply with these changes?
What are the penalties if a cigarette package or advertisement is found out of compliance?
Are retailers subject to enforcement penalties?
Will this regulation apply to small businesses (e.g., small tobacco manufactures)?
Substantial Equivalence
How does the Tobacco Control Act define substantial equivalence?
To what products does substantial equivalence apply?
Guidances
Vaccines, Blood, Biologics
Vaccines, Blood, Biologics Review Process
Importing Biologics
What information do I need to import a biological product for research use only?
How do I import a biological product regulated by FDA?
Devices Regulated by CBER
What medical devices does CBER regulate?
Where can I find a list of devices approved/cleared by CBER?
Registration Basics
I work in a hospital transfusion service - do we need to register with FDA?
How do I register my HCT/P establishment?
How do I register my blood establishment?
What is the status of my registration?
General Information
What should I do if the FDA form I need to use has expired?
Where can I find information on whether or not I need to file an IND application for a biological product?
