Accredited Persons Inspection Program

Overview
Manufacturer Eligibility
How to Request an Inspection by an AP
FDA Denial of Request To Use an AP
Re-Establishing Eligibility
Limits to the Number of AP Inspections That Can Be Performed
List of Accredited Persons
Guidance Documents

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.

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
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: carsten.worm.jensen@presafe.com
Foreign Certification/Recognition: All Member States of the European Community
Types of Devices: All Medical Devices
Firm Name: DQS Medizinprodukte GmbH
Address: August Schanz Strasse 21
City, State: 60433 Frankfurt
Country: Germany
Contact Name: Maxim Shkolnikov
Phone: +49 (0) 69-95427-236, +49 (0) 69-95427-300
Fax: +49 (0) 69-95427-388
Email: Maxim.Shkolnikov@dqs-med.de
Foreign Certification/Recognition: All Member States of the European Community, Canada
Types of Devices: All Medical Devices
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
Firm Name: Center for Measurement Standards/Industrial Technology Research Institute (CMS/ITRI) *
Address: Bldg. 4, 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 2299
Email: alberttwli@itri.org.tw
Foreign Certification/Recognition: Taiwan
Types of Devices: All Medical Devices
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
Internet: www.dekra-certification.com
Foreign Certification/Recognition: All Member States of the European Community, Canada
Types of Devices: All Medical Devices
Firm Name: Orion Registrar, Inc. *
Address: 7502 W 80th Avenue, Suite 225
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
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
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
Firm Name: TUV Rheinland of North America, Inc.*
Address: 295 Forster St., Suite 100
City, State: Littleton, MA 01460
Country: USA
Phone: (978) 266-9500 x4234
Fax: (978) 266-9992
Email: bludovico@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.