Industry Frequently Asked Questions

Below are frequently asked questions and the associated answers sorted by topic area. 

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Animal & Veterinary

Drug Review

What information and types of notifications are provided to sponsors during the new animal drug application review process?

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?

You have a developed a dog food or treat and want to manufacture and market it. Are there rules or requirements you should know about?

Reporting

What is the process for Veterinary Adverse Event Reporting for Manufacturers?

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Cosmetics

Does the FDA approve cosmetics before they go on the market?

Does the FDA pre-approve cosmetic product labeling?

Registration & Listing of Cosmetic Product Facilities and Products

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?

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Drugs

Drug Review

What information is provided to sponsors during the human drug product application review process?

How is a sponsor of a product application that is subject to PDUFA target dates informed about whether the review of its product application is on track to meet the target date for FDA action on the application?

Drug Approval

How can I better understand Patents and Exclusivity?

I wish to market an OTC drug product – where do I start?

I own a small pharmaceutical business. Am I eligible for, and if so, how do I apply for a PDUFA waiver?

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?

Guidance

Where can I find industry guidances applicable to human drug products? How can I easily retrieve newly added guidances?

Drug Registration and Listing

If I am required to register my drug facility and list my drug product, how do I proceed?

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Food

Allergen Labeling

Where do the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) come from?

What is a “major food allergen?”

Can FDA add other allergens to the current list of major food allergens?

Do the allergen labeling requirements of the FD&C Act provide specific direction for declaring the presence of ingredients from the three food groups that are designated as “major food allergens (i.e., tree nuts, fish, and Crustacean shellfish?”)

Do food allergen labeling requirements apply to bulk containers like reusable totes or containers, etc.? 

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?

Food Safety Modernization Act (FSMA)

View FSMA Frequently Asked Questions

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Medical Devices

Medical Device Review Process

What information and types of notifications are provided to sponsors during the medical device application 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?

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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

Is it acceptable to contact CDRH to get guidance on the meaning of specific requirements of a performance standard or applicable regulation?

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Vaccines, Blood, Biologics

Vaccines, Blood, Biologics Review Process

What information and types of notifications are provided to sponsors during the human biologic product application 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 get information on donor eligibility for human cells, tissues and cellular- and tissue-based products (HCT/Ps)?

Where can I find information on whether or not I need to file an IND application for a biological product?

Under what circumstances is it appropriate to use secure e-mail between FDA and a manufacturer when there is a question involving the manufacturer’s product?

How is a sponsor of a product application that is subject to PDUFA target dates informed about whether the review of its product application is on track to meet the target date for FDA action on the application?