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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Postmarket Requirements (Devices)
  5. Third-Party Inspection (Devices)
  6. Inspection by Accredited Persons Program
  1. Third-Party Inspection (Devices)

Inspection by Accredited Persons Program

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Overview

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law on October 26, 2002. MDUFMA authorized the FDA to accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices. The owner or operator of such an establishment that is eligible may select an Accredited Person (AP), from the list below to conduct such inspections. On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) further amended this voluntary third-party inspection program by revising eligibility criteria.

Manufacturer Eligibility

To be eligible for inspection by an Accredited Person, a device establishment must meet the following conditions under section 704(g)(6)(A) of the Federal Food, Drug, and Cosmetic Act (the Act):

  • The establishment's most recent inspection was classified by the FDA as No Action Indicated or Voluntary Action Indicated (see section 704(g)(6)(A)(i) of the Act).
  •  The owner or operator of the establishment submits a notice to the FDA that (see section 704(g)(6)(A)(ii)(I-IV) of the Act):
    • Provides the date of the last inspection and the classification of that inspection
    • States the intention of the owner or operator to use an Accredited Person to conduct inspections of the establishment
    • Identifies the particular Accredited Person, the owner or operator intends to select to conduct such inspection
    • Includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment –
      • At least 1 of such devices is marketed in the United States; and
      • At least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited and identified as a person authorized to conduct inspections of device establishments.

A device establishment intending to be inspected by an Accredited Person may contact the FDA at CDRH_Accredited_Persons_Inspection@fda.hhs.gov to determine eligibility.

List of Accredited Persons for Inspection

Manufacturers interested in participating in the program must select an Accredited Person (AP) from the organizations listed below in alphabetical order. Applications for accreditation under the Inspection by Accredited Persons (IAP) Program from these organizations have been evaluated by FDA's Third Party Recognition Board and have met the criteria published in the Federal Register on October 4, 2004 (69 FR 59250).

APs reflecting an asterisk have at least one inspector that has completed training and is currently qualified to conduct independent inspections under the IAP Program.

  1. Firm Name: Center for Measurement Standards/Industrial Technology Research Institute (CMS/ITRI) *
    Address: Bldg. 1, 321 Kuang Fu Rd., Sec. 2
    City, State: Hsinchu, Taiwan 30011
    Country: Republic of China
    Contact Name: Mr. Tzu-Wei Li
    Phone: +886 3 573 2227
    Fax: +886 3 573 4092
    Email: alberttwli@itri.org.tw
    Types of Devices: All Medical Devices
     
  2. Firm Name: DEKRA CERTIFICATION B.V. (formerly KEMA Quality B.V.)
    Address: Meander 1051
    City, State: Arnhem NL 6825 MJ
    Country: The Netherlands
    Contact Names: Mr. Harry Van Vugt, Third Party 510(K) Program Manager
    Phone: +31 88 96 83000
    Fax: +31 88 96 83100
    Email: medical.nl@dekra.com
    Types of Devices: All Medical Devices
  1. Firm Name: DQS Medizinprodukte GmbH
    Address: August Schanz Strasse 21
    City, State: 60433 Frankfurt
    Country: Germany
    Contact Name: Szymon Kurdyn
    Phone: +49 (0) 69-95427-507, +49 (0) 69-95427-300
    Fax: +49 (0) 69-95427-388
    Email: szymon.kurdyn@dqs-med.de
    Types of Devices: All Medical Devices
     
  2. Firm Name: Presafe Denmark A/S
    Address: Tuborg Parkvej 8
    City, State: DK-2900 Hellerup
    Country: Denmark
    Contact Name: Mr. Ben Buus
    Phone: +45 3945 4999
    Email: bent.buus@dnvgl.com   
    Types of Devices: All Medical Devices
     
  3. Firm Name: QS Zürich AG
    Address: P.O. Box 6335
    City, State: CH 8050 Zürich
    Country: Switzerland
    Contact Name: Mr. Lukas Beljean
    Phone: +41 1 350 46 65
    Fax: +41 1 350 46 69
    Email: info@quality-service.ch
    Types of Devices: All Medical Devices, except IVDs
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