Regulatory Process

General Navigation Guide for Manufacturers of FDA-Regulated Products and Start-ups

What does FDA regulate?

What doesn’t FDA regulate? How do I contact the agencies that do?

Comment on Open Dockets:

FDA Open Dockets on Regulations.gov 

FDA Federal Registers

Dispute Resolution Process 

The FDA Office of the Ombudsman is the agency's focal point for addressing complaints and assisting in resolving disputes between companies or individuals and FDA offices concerning fair and even handed application of FDA policy and procedures. It serves as a neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level. It works to resolve externally and internally generated problems for which there are no legal or established means of redress by finding approaches that are acceptable to both the affected party and to the agency. More about the Office of the Ombudsman.

Animal and Veterinary

• CVM Ombudsman 

Biologics

• CBER Ombudsman
• Guidance - Formal Dispute Resolution (Appeals Above the Division Level) (PDF - 30KB)

Drugs

• CDER Ombudsman
• Guidance - Formal Dispute Resolution (Appeals Above the Division Level) (PDF - 30KB)

Medical Devices

• Resolution of Difference of Opinion

Radiation-Emitting Products

• CDRH Ombudsman

Tobacco Products

• CTP Ombudsman

Laws and Regulations

• Code of Federal Regulations (Title 21)
• Federal Food, Drug, and Cosmetic Act
• Other Laws Affecting FDA