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:

        Postmarket Requirements (Devices)

Third-Party Inspection (Devices) Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Postmarket Requirements (Devices)
          Third-Party Inspection (Devices)Postmarket Requirements (Devices) Third-Party Inspection (Devices)
  	
        Share
    Post
    Linkedin

    Email
    PrintMedical Device Single Audit Program (MDSAP)

From January 1, 2014 to December 31, 2016), FDA collaborated with international partners to participate in the Medical Device Single Audit Program (MDSAP) Pilot. The MDSAP Pilot allows an MDSAP-recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (that is, the international MDSAP governing body) determined that the MDSAP Pilot satisfactorily demonstrated the viability of the program. Since January 2017, the MDSAP has transitioned from pilot to fully operational status. FDA will continue to accept MDSAP audit reports as a substitute for routine FDA inspections.

Additional Information on MDSAP****
	List of MDSAP Auditing Organizations****
	List of MDSAP Regulatory Authorities****Accredited Persons Inspection Program

The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 was signed into law on October 26, 2002. Section 201 of MDUFMA establishes a new subsection "g" to section 704 (Factory Inspection) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which requires FDA to accredit third parties (Accredited Persons) to perform inspections of eligible manufacturers of Class II or III devices. This is a voluntary program. While all firms remain subject to inspection by FDA, eligible manufacturers have the option of requesting inspection by an Accredited Person (AP). However, inspections by APs are limited to manufacturers who meet certain conditions under Section 704(g0(6)(A) of the FD&C Act.

Additional Information on the Accredited Persons Inspection Program (Including a List of Authorized Accredited Persons)

                                                                                  Content current as of:
      01/30/2019
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsThird-Party Inspection (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