# Presentation: 753197

## Inspection by Accredited Persons (AP) Program

**November 18, 2004**

## Today’s Topics	

**Purpose of program**
**Overview and features of program**
**Current status**
**Contacts and resources**

## 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**

## 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**

## 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   **

## 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**

## 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).**

## 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****)**

## 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**

## 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 **

## 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 **

**Notes:**
6 auditors have resigned/retired

## 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**

## Contacts and Resources

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

## 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**