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.
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: DS Certificering A/S (DGM)
*
Address: Kollegievej 6
City, State: DK-2920 Charlottenlund
Country: Denmark
Contact Name: Mr. Carsten Worm Jensen
Phone: +45 3996 6400
Fax: +45 7224 5903
Email: CWJ@dscert.dk
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: Lloyd’s Register Quality Assurance, Inc. (LRQA)
Address: 1401 Enclave Parkway, Suite 200
City, State: Houston, Texas 77077
Country: United States of America
Contact Name: Mr. Pedro (Pete) Gonzalex
Phone: (281) 398-7370
Fax: (281) 398-7337
Email: pedro.gonzalez@lrqa.com
Foreign Certification/Recognition: All Member States of the European Community, Canada
Types of Devices: All Medical Devices |
|
|
10. |
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 |
|
|
11. |
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 |
|
|
12. |
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 |
|
|
13. |
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 |
|
|
14. |
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 |
|
|
15. |
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 |
|
|
16 |
Firm Name: Underwriters Laboratories (UL), Inc.
Address: 333 Pfingsten Road
City, State: Northbrook, IL 60062-2096
Country: USA
Contact Name: Rick Titus
Phone: +1 (847) 664-3281
Fax: +1 (847) 272-8129
Email: Rick.A.Titus@us.ul.com
Foreign Certification/Recognition: Canada
Types of Devices: All Medical Devices
|
* AP auditor has completed qualifying inspections and can conduct independent
inspections.
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Updated November 3, 2008
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