Inspection by Accredited Persons (AP) Program

1. Inspection by Accredited Persons (AP) Program November 18, 2004

2. Today’s Topics • Purpose of program • Overview and features of program • Current status • Contacts and resources

3. Purpose • Manufacturers may schedule AP and other inspections simultaneously • Saves time • More efficient use of scarce FDA limited resources • More information about more firms • Able to visit firms otherwise unable to

4. Overview • Authorized under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) • FDA to accredit third parties, Accredited Persons (APs), to conduct inspections of eligible manufacturers of Class II and III devices

5. Primary Features of the Program • Process for inspection • Eligible establishment selects AP from list • Fee negotiated among parties (not FDA funded) • Firm requests to FDA to use AP and FDA approval/denial • With approval, AP assesses quality system and determines compliance • AP prepares/submits report to FDA • FDA makes final compliance determination

6. Primary Features of the Program (continued) • Very strict conflict of interest provisions for APs • Pre-approval, BiMo and “for cause” inspections conducted exclusively by FDA • FDA retains right to inspect in accordance with Section 704 of the Act

7. Technical Changes: Eligibility • Most recent FDA inspection is NAI or VAI • Markets a Class II or III device in U.S., and: • Device is marketed/intended to be marketed in one or more foreign countries; • AP is certified, accredited or otherwise recognized by one of the foreign countries as a person authorized to conduct inspections; and/or • laws of one of the foreign countries where device is (to be) sold recognizes an inspection by FDA or by a person accredited (as described in the Act).

8. Accreditation Criteria • Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria • initially issued April 28, 2003 was revised and reissued on October 4, 2004(http://www.fda.gov/cdrh/mdufma)

9. Implementation Milestones • October 24, 2003 – FDA listed 15 APs on Internet • 9 foreign base, 6 domestic • April 28, 2004 – new applicants could apply for accreditation under the program

10. Implementation Milestones cont. • 43 auditors attended FDA training in January, 2004 • Approximately 1/3 had completed AAMI training thus could start joint audits • 16 MRA auditors were provided evidence development training in February, 2004 • All successfully completed training/exam • 59 candidates total

11. Current Status • 4 AP firms have 2 auditors each who have completed all training and joint audits and can conduct independent inspections • Approximately half of all eligible auditors have conducted at least their first joint audit

12. How Can Industry Help? • We heartily encourage qualified manufacturers to participate and consider hosting a joint performance audit • Class II or III device • last FDA inspection classified NAI or VAI & conducted at least 20 months ago • contact ORA Division of Field Investigations

13. Contacts and Resources • Office of Regulatory Affairs/ Division of Field Investigations: • email: ORAHQAPProgram@ora.fda.gov • phone: (301)827-5653 • fax: (301)827-6685

14. Contacts and Resources • FDA’s CDRH webpage: • http://www.fda.gov/cdrh • MDUFMA webpage: • http://www.fda.gov/cdrh/mdufma • DSMICA: • e-mail: dsmica@cdrh.fda.gov • phone: 800-638-2041; fax: 301-443-8818 • John Stigi, DSMICA/CDRH: • phone: 800-638-2041, ext. 124 • e-mail: jfs@cdrh.fda.gov