Medical Devices

Accredited Persons Inspection Program


Overview

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law on October 26, 2002. MDUFMA authorizes Accredited Persons (AP) to conduct medical device facility inspections. An AP is a third party recognized by FDA to:

  • assess the quality system of eligible manufacturers of Class II and III devices under 21 CFR Part 820;
  • determine compliance with other device requirements in the act and regulations;
  • and prepare and submit reports to FDA, who makes the final compliance assessment.

An inspection by an Accredited Person is an alternative to the traditional inspection by an FDA official. An AP can evaluate a manufacturer's compliance with the Quality System regulation (21 CFR Part 820) and other FDA regulations and submit the findings to FDA for final determination.

Participation in the program is entirely voluntary. Eligible manufacturers may request to utilize an AP or continue to have FDA perform inspections.

FDA will make periodic on-site visits to each AP to audit performance and inspect records, correspondence, and other materials relating to the Inspection by APs Program. FDA will monitor and evaluate APs' independence and compliance with section 704(g) of the Food, Drug, and Cosmetic Act.

Detailed discussion of the AP inspection program can be found in Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.


Manufacturer Eligibility

Not all device establishments are eligible for inspection by an AP. In order to be eligible to employ an AP in lieu of an inspection by FDA, establishments must meet the following basic criteria under section 704(g)(6)(A) of the act:

  • The establishment's most recent inspection was classified by FDA as No Action Indicated (NAI) or Voluntary Action Indicated (VAI);
  • The establishment submits a notice to FDA requesting clearance (approval) to use an AP and identifying the AP it intends to use, and FDA agrees to the use of the selected AP;
  • The establishment markets a device in the United States and markets or intends to market a device in one or more foreign countries;
  • The AP is certified, accredited, or otherwise recognized by one of the foreign countries in which the device is to be marketed;
  • The establishment submits a statement that the laws of one of the countries in which the device is to be marketed recognizes an inspection of the establishment by FDA.

The intent of these provisions is to focus the use of third party inspections on manufacturers that operate in a global market and are likely to be subject to multiple inspection requirements.


How to Request an Inspection by an AP

FDA has issued additional guidance with details about requesting a third party inspection. In general, however, the establishment will send a notice to the applicable Office of Compliance in CDRH or CBER requesting clearance (approval) to employ a specific third party to do a Quality System inspection in lieu of a required FDA inspection. FDA must respond within 30 days of receiving an establishment's notice requesting clearance to employ an AP to conduct an inspection. If FDA fails to respond to a notice within 30 days, the establishment is deemed to have clearance to use the AP it selected. FDA's response to a notice may include:

  • Approval to use the selected AP;
  • Denial of clearance to use the selected AP; or
  • A request for additional information concerning:
    • compliance data showing whether the establishment has consistently complied with QS/GMP requirements and promptly corrected any problems; this data must include complete reports of inspections or other quality control audits made during the preceding two years, as well as other compliance data FDA deems necessary. The establishment is responsible for providing this information to FDA; and/or
    • the relationship between the establishment and the AP, including information on previous inspections of the manufacturer or any related manufacturers. FDA may request this information from either the establishment or the AP.

When FDA requests additional information, the statute requires FDA to either provide or deny clearance to use the selected AP within 60 days of receiving the additional information. If FDA denies the request, the reasons for denial will be stated. If FDA does not respond, the selection is deemed to have been accepted.


FDA Denial of Request To Use an AP

If FDA denies an establishment's request for clearance (approval) to use an AP to do an inspection in lieu of an FDA inspection, the establishment may request a review of FDA's decision within 30 days of receiving FDA's decision. This review will be conducted by a person designated by FDA and will begin within 30 days of the request for review.

If FDA rejects an establishment's selection of an AP, the establishment may:

  • Submit another notice, selecting a different AP. This notice is treated in the same manner as an original request;
  • Request a review of FDA's decision within 30 days of receiving FDA's decision. This review will be conducted by a person designated by FDA and will begin within 30 days of the request for review.

Re-Establishing Eligibility

If an establishment is inspected by an AP and receives an Official Action Indicated (OAI) determination from FDA following the inspection, the establishment becomes ineligible to use an AP again until:

  • The establishment meets the basic (5) criteria under Section III B above for eligibility for inspection by AP;
  • FDA issues a "written statement" upon request that the OAI violations have been resolved; and
  • Upon petition of the establishment or on FDA's own initiative, FDA informs the establishment that it has clearance to use an AP for inspections. If the establishment submits a petition, FDA must by law respond within 30 days.

Limits to the Number of AP Inspections That Can Be Performed

In general, an AP may not perform more than two consecutive inspections of a particular establishment unless the establishment petitions FDA for and receives a waiver. This provision of MDUFMA is intended to ensure periodic inspections by FDA. Additional information on how to request a waiver can be found in Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.


List of Accredited Persons for Inspection

Applications for accreditation under the Inspection by Accredited Persons (IAP) Program are evaluated by FDA’s Third Party Recognition Board (TPRB) based on criteria published in the Federal Register on April 28, 2003 (68 FR 22400). The applications from these "Accredited Persons" met the criterial for accreditation and are listed below in alphabetical order. Please note that fees may vary among the Accredited Persons.

FDA is currently developing guidance to help establishments determine whether they are qualified to participate in the third party inspection program. Because all Accredited Persons will have to complete training before conducting independent inspections under the new program, many of these APs will not be available to companies for several months. 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. In the meantime, any company that is interested in participating in the third party inspection program may contact CDRH to get more information about eligibility.

  1. Firm Name: AMTAC Certification Services Limited
    Address: Davy Avenue, Knowlhill
    City, State: Milton Keynes, Buckinghamshire, MK5 8NL
    Country: United Kingdom
    Contact Name: Mr. Ron Nash
    Phone: +44 (0) 1908 857750
    Fax: +44 (0) 1908 857751
    Email: ron.nash@intertek.com
    Foreign Certification/Recognition: All Member States of the European Community, Canada
    Types of Devices: All Medical Devices
     
  2. Firm Name: BSI*
    Address: 12110 Sunset Hills Road, Suite 200
    City, State: Reston, Virginia 20190 - 3231
    Country: USA
    Contact Name: Mr. Paul Brooks
    Phone: +1 (703) 437-9000 (direct dial +1(703) 464-1923)
    Fax: +1 (703) 437-9001
    Email: paul.brooks@bsi-global.com
    Foreign Certification/Recognition: United Kingdom, Canada, Taiwan
    Types of Devices: All Medical Devices
     
  3. Firm Name: Presafe Denmark A/S
    Address: Tuborg Parkvej 8
    City, State: DK-2900 Hellerup
    Country: Denmark
    Contact Name: Mr. Carsten Worm Jensen
    Phone: +45 3945 4999
    Email: carsten.worm.jensen@presafe.com  
    Foreign Certification/Recognition: All Member States of the European Community
    Types of Devices: All Medical Devices
     
  4. Firm Name: DQS GmbH
    Address: August Schanz Strasse 21
    City, State: 60433 Frankfurt
    Country: Germany
    Contact Name: Dr. Peter Greve
    Phone: +49 (0) 69-95427-361
    Fax: +49 (0) 69-95427-388
    Email: Peter.Greve@dqs.de
    Foreign Certification/Recognition: All Member States of the European Community, Canada
    Types of Devices: All Medical Devices
     
  5. Firm Name: LNE Laboratoire National de metrologie et d'Essais (G-MED Certification Division) *
    Address: 1, rue Gaston Boissier
    City, State: 75724 PARIS Cedex 15
    Country: France
    Contact Name: Ms. Corinne Delorme
    Phone: +33 1-40-43-39-72
    Fax: +33-1-40-43-37-37
    Email: corinne.delorme@lne.fr
    Foreign Certification/Recognition: All Member States of the European Community, Canada, Taiwan, Australia, New Zealand
    Types of Devices: All Medical Devices
     
  6. Firm Name: Intertek Testing Services
    Address: 70 Codman Hill Road
    City, State: Boxborough, MA, 01719
    Country: USA
    Contact Name: Christine Forcier
    Phone: (514) 631-3100
    Fax: (514) 631-0882
    Email: christine.forcier@intertek.com
    Foreign Certification/Recognition: Netherlands, Canada
    Types of Devices: All Medical Devices, except IVDs
     
  7. Firm Name: Center for Measurement Standards/Industrial Technology Research Institute (CMS/ITRI) *
    Address: Bldg. 16, 321 Kuang Fu Rd., Sec. 2
    City, State: Hsinchu, Taiwan 30042
    Country: Republic of China
    Contact Name: Mr. Tzu-Wei Li
    Phone: +886 3 573 2227
    Fax: +886 3 573 2299
    Email: alberttwli@itri.org.tw
    Foreign Certification/Recognition: Taiwan
    Types of Devices: All Medical Devices
     
  8. Firm Name: KEMA Quality B.V.
    Address: Utrechtseweg 310
    City, State: 6812 Arnhem
    Country: The Netherlands
    Contact Name: Ir. J.H. van Lochem MBM
    Phone: +31 26 356 3224
    Fax: +31 26 3 5156 06
    Email: jan.vanlochem@kema.com
    Foreign Certification/Recognition: All Member States of the European Community, Canada
    Types of Devices: All Medical Devices
     
  9. Firm Name: Orion Registrar, Inc. *
    Address: 7850 Vance Drive, Suite 210
    City, State: Arvada, Colorado 80003
    Country: USA
    Contact Name: Mr. Paul Burck
    Phone: (303) 456-6010
    Fax: (303) 456-6681
    Email: pburck@orion4value.com
    Foreign Certification/Recognition: Norway
    Types of Devices: All Medical Devices
     
  10. Firm Name: Quality Management Institute (QMI)
    Address: 20 Carlson, Suite 100
    City, State: Toronto, Ontario M9W 7K6
    Country: Canada
    Contact Name: Ms. Josee Adam
    Phone: (514) 428-2490
    Fax: (514) 694-9697
    Email: jadam@qmi.com
    Foreign Certification/Recognition: Canada, Mexico
    Types of Devices: All Medical Devices, except Immunology, Microbiology, Neurological, and OB-GYN Devices
     
  11. Firm Name: QS Zürich AG
    Address: P.O. Box 6335
    City, State: CH 8050 Zürich
    Country: Switzerland
    Contact Name: Mr. Eugen Moor
    Phone: +41 1 350 46 65
    Fax: +41 1 350 46 69
    Email: qs-zuerich@quality-service.ch
    Foreign Certification/Recognition: Switzerland, All Member States of the European Community
    Types of Devices: All Medical Devices, except IVDs
     
  12. Firm Name: SGS United Kingdom Limited *
    Address: 202B Worle Parkway
    City, State: Weston-super-Mare, BS22-6WA
    Country: United Kingdom
    Contact Name: Mr. Christopher Jepson
    Phone: +44 1934 522917
    Fax: +44 1934 522137
    Email: Chris_Jepson@sgs.com
    Foreign Certification/Recognition: All Member States of the European Community
    Types of Devices: All Medical Devices
     
  13. Firm Name: TÜV SÜD America Inc. *
    Address: 10 Centennial Drive
    City, State: Peabody, Massachusetts 01960
    Country: USA
    Contact Name: Gary W. Minks
    Phone: 978-573-2521
    Fax: 978-977-0157
    Email: gminks@tuvam.com
    Foreign Certification/Recognition: Canada, Taiwan
    Types of Devices: All Medical Devices
     
  14. Firm Name: TUV Rheinland of North America, Inc.*
    Address: 1300 Massachusetts Avenue, Suite 103
    City, State: Boxborough, MA 01719
    Country: USA
    Contact Name: Gregor Dzialas
    Phone: (978) 266-9500 x227
    Fax: (978) 266-9992
    Email: GDzialas@us.tuv.com
    Foreign Certification/Recognition: Canada, Taiwan
    Types of Devices: All Medical Devices

* AP auditor has completed qualifying inspections and can conduct independent inspections.

Page Last Updated: 09/03/2014
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