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:

                Home Use Devices

Home Use Devices

                        Home Use Devices Initiative
          Unique Considerations in the Home
          Specific Devices for Home Use
          Frequently Asked Questions About Home Use Devices
          FDA's Role in Regulating Medical Devices
          FDA Activities:  Home Use Devices
          Additional Resources on Home Use Devices Home
          Medical Devices
          Products and Medical Procedures
          Home Health and Consumer Devices
          Home Use Devices
          FDA's Role in Regulating Medical DevicesHome Use Devices FDA's Role in Regulating Medical Devices
  
  	
    Share
    Post
    Linkedin

    Email
    PrintFDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products.

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

The FDA does not have the authority to:

Regulate a physician's or nurse's practice.  FDA does not tell providers what to do when running their business or what they can or cannot tell their patients.
	Make recommendations for individual doctors, clinics, or home care agencies.
	Conduct or provide a rating system on any regulated medical devices.FDA monitors the ongoing safety and efficacy of regulated marketed devices through MedWatch, the FDA  Safety Information and Adverse Event Reporting Program.  MedWatch allows manufacturers, health care professionals and consumers to report serious problems related to the use of drugs and medical devices.

MedWatch
	Report a problem with a medical device
	Search for reported medical device problemsAdditional Information

Learn if a Medical Device Has Been Cleared by FDA for Marketing

                                                                                  Content current as of:
      08/31/2018
              
              
Regulated Product(s)
		 Medical DevicesHome Use Devices

          
                        Home Use Devices Initiative
          Unique Considerations in the Home
          Specific Devices for Home Use
          Frequently Asked Questions About Home Use Devices
          FDA's Role in Regulating Medical Devices
          FDA Activities:  Home Use Devices
          Additional Resources on Home Use Devices
 
 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