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.

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