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 In this section:

        Safety

Report a Problem to the FDA

                        
                When and Where to Report Emergencies
          How to Report a Non-Emergency
          Reporting Unlawful Sales of Medical Products on the Internet


                Consumer Complaint Coordinators
          Questions and Answers: Problem Reporting Home
          Safety
          Report a Problem to the FDASafety Report a Problem to the FDA
  	
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    PrintWhat products does FDA regulate?

Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled. It also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, animal food (including pet food) and animal drugs, and electronic products that emit radiation (such as microwave ovens and video monitors), ensuring that these products are safe and effective. FDA also regulates tobacco products.

Why should I report?

The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people.

When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

For Use By
			Form**Health Professionals, Patients, and Consumers**
			Easy online, voluntary reporting for health professionals, patients, and consumers.
			Online Reporting Form**Health Professionals**
			For use by health professionals, consumers, and patients. Instructions for Completing Form FDA 3500
			Form FDA 3500 - Voluntary Reporting****(pdf)**Patients and Consumers**
			A consumer-friendly version of the 3500 reporting form.
			Form FDA 3500B - Voluntary Reporting for Consumers****(pdf)**Industry (Mandatory)**
			Reporting by IND reporters, manufacturers, distributors, importers, user facilities personnel.
			These particular reports must be submitted in an electronic format that FDA can process, review, and archive.  See the guidance for industry “Providing Submissions in Electronic Format —Postmarketing Safety Reports”.**Pacientes y consumidores**
			Para uso de pacientes y consumidores.
			Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B(pdf)

Regulated Medical Product
			Website**Tobacco, Cigars, E-cigarettes/Vaping and Chewing Tobacco**
			For use by health professionals, consumers, and patients.
			Safety Reporting Portal**Vaccines**
			For use by health professionals, consumers, and patients.
			Vaccine Online Reporting**Animal Food, Drugs and Devices**
			For use by industry, veterinarians and animal owners.
			Report a problem with an animal or veterinary product**Dietary Supplements**
			For use by health professionals, consumers, and industry
			Safety Reporting Portal

                                                                                  Content current as of:
      08/02/2023Report a Problem to the FDA                
                          

                        When and Where to Report Emergencies
          How to Report a Non-Emergency
          Reporting Unlawful Sales of Medical Products on the Internet


                        Consumer Complaint Coordinators
          Questions and Answers: Problem Reporting
 
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