Third Party Audit Program:

1
Third Party Audit Program

• HCIA Conference
• Buffalo Rochester, NY
• June 22nd 23rd, 2004

2

• On October 26, 2002, the President signed onto
  law the Medical Device User Fee and Modernization
  Act of 2002 (MDUFMA).

3

• Section 201 of MDUFMA requires FDA to accredit
  persons to perform independent inspections of
  eligible manufacturers of Class II and Class III
  medical devices.

4

• An Accredited Person is merely an entity, and not
  necessarily an individual. An AP may have many
  employees.
• Participation in the program is strictly
  voluntary.

5
Eligible Manufacturers?

• The establishments most recent inspection was
  classified by FDA as NAI or VAI.
• The establishment submits a notice to FDA
  requesting clearance (approval) to use an AP and
  identifies the AP it intends to use, and FDA
  agrees to the use of the selected AP.

6
Eligible Manufacturers?

• 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 and

7
Eligible Manufacturers?

• 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.

8
Certification of AP auditor?

• Joint inspections including both FDA Investigator
  AP Auditor.
• 1. Training Audit FDA is Lead and AP Auditor
  observes.
• 2. Collaborative Audit AP Auditor is Lead and
  FDA Investigator participates as necessary.
• 3. Full Performance Audit AP Auditor is totally
  responsible for inspection and FDA Investigator
  only observes.

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• All AP Inspections will minimally include a Level
  II QSIT inspection and cover other applicable
  areas as directed by the CP/Assignment Request.

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• Additional Information, including a current
  listing of the accepted CABs
• www.fda.gov/cdrh/ap-inspection/ap-inspection.html

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• ANY
• VOLUNTEERS
• ?????????
• See me at any time during the
  conference!