Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA Basics for Industry

FDA Basics for Industry

                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments Home
          For Industry
          FDA Basics for Industry
          Regulatory ProcessFDA Basics for Industry Regulatory Process
  
  	
    Share
    Post
    Linkedin

    Email
    PrintGeneral 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 OmbudsmanBiologics

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 OpinionRadiation-Emitting Products

CDRH OmbudsmanTobacco Products

CTP OmbudsmanLaws and Regulations

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

                                                                                  Content current as of:
      10/26/2021FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop