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Draft Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties


Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002

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This guidance document is being distributed for comment purposes only.

Document issued on: June 3, 2004


Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact, Casper Uldriks 301-594-4692 ceu@cdrh.fda.gov for CDRH issues or Carol Rehkopf, 301-827-6202, Rehkopf@cber.fda.gov for CBER issues.

 

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Contains Nonbinding Recommendations

Draft - Not for Implementation

Preface

Additional Copies

Additional copies are available from the Internet at: http://www.fda.gov/cdrh/comp/guidance/1532.pdf. or to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1532) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Draft Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties


Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. Introduction

Manufacturers of Medical Devices May Be Eligible To Have Third-Party Inspections of Their Establishments

Section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) amends section 704 of the Federal Food, Drug, and Cosmetic Act (the act) by adding subsection (g). (21 U.S.C. 374(g)). This amendment authorizes FDA to establish a voluntary third party inspection program applicable to manufacturers of Class II or Class III medical devices who meet certain eligibility criteria. Under this new Inspection by Accredited Persons Program (AP Program), such manufacturers may elect to have third parties that have been accredited by FDA (accredited person or AP) conduct some of their inspections instead of FDA.

The AP Program applies to manufacturers who currently market their medical devices in the United States and who also market or plan to market their devices in foreign countries. Such manufacturers may need current inspections of their establishments to operate in global commerce.

One benefit of the new program is that it will allow manufacturers greater control over the timing of their inspections. In addition, because some of the APs accredited by FDA are already recognized by other countries as persons authorized to conduct inspections of device establishments, it is possible that in some cases a single AP inspection will meet the requirements of more than one regulatory authority, thereby reducing the need for multiple inspections of the same establishment.

This guidance will help device establishments determine whether they are qualified to participate in the AP Program. Any establishment that is interested in obtaining additional information about eligibility or other matters addressed in this document may contact CDRH. Because the APs who have been approved by FDA will have to complete training before they may begin conducting independent inspections under the new program, the APs will not be available to companies for several months from the date of this guidance.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Discussion

Under the act, domestic manufacturers of Class II or Class III medical devices must be inspected for compliance with Good Manufacturing Practice (GMP) requirements and other applicable requirements at least once every two years. (21 U.S.C. 360(h)). One major benefit of the AP Program is that it enables eligible manufacturers to schedule such inspections at the same time they will be inspected by other regulatory authorities or organizations, thereby reducing the number of disruptions to the establishment's normal operations.

Following the enactment of MDUFMA, FDA accredited 15 APs to perform inspections under the AP Program. FDA used stringent selection criteria in its selection of APs to help ensure that third-party inspections under this program do not present any actual or apparent conflicts of interest. Those APs who were selected are in the process of completing training so they can soon begin conducting independent inspections under the AP Program. Once independent AP inspections are underway, FDA will review the reports prepared by the APs following inspection to determine if your firm is in compliance with GMPs and other requirements.

The list of APs prepared by FDA is available on the Internet at http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html. You may select any of the APs listed, provided you meet all of the eligibility criteria for the AP Program. The next section of this guidance describes in detail the eligibility criteria applicable to manufacturers who wish to participate in the AP Program.

III. Information about how to participate in the AP Program

Who may participate in the AP Program?

The AP Program is open to domestic U.S. device establishments, as well as foreign establishments that are required to register with FDA under section 510(i) of the act, provided such establishments otherwise meet the program's eligibility criteria.

What are the eligibility requirements for participating in the AP inspection program?

Based on requirements found at Section 704(g) of the act, you must satisfy the following criteria in order to be eligible to participate in the program:

  1. You "manufacture, prepare, propagate, compound, or process" class II or class III medical devices. (Sec. 704(g)(1) of the act.) The shorthand term "manufacture" will be used for convenience throughout this document instead of listing each of these activities (i.e., "manufacture, prepare, propagate, compound, or process") repeatedly. ;
  1. You market at least one of the devices in the United States;
  1. You market or intend to market at least one of the devices in one or more foreign countries and one or both of the following two conditions are met:

    (a) One of the foreign countries certifies, accredits, or otherwise recognizes the AP you have selected as a person authorized to conduct inspections of device establishments, or

    (b) Your firm submits a statement that the law of a country where you
    market or intend to market your devices recognizes an inspection by the FDA
    or by the AP. (Sec. 704(g)(6)(A)(iii)(I), (II) of the act.);

  1. Your most recent inspection performed by FDA, or by an AP under this program, was classified by FDA as either "No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI).” (Sec. 704(g)(6)(A)(i) of the act.); and
  1. You submit a notice to FDA requesting clearance (approval) to use an AP, identify the AP you selected, and FDA agrees to the use of the selected AP. (Sec. 704(g)(6)(A)(ii).).

A. Device Eligibility Requirements1

Is your medical device eligible?


1Unless otherwise noted, a reference to “requirements” in the following section refers to the requirements under section 704(g) of the act.


How can you show that you market or intend to market a device in a foreign country?

The following are examples of ways you can show that you market or intend to market a device in a foreign country:


Is it necessary that one of the devices marketed or intended to be marketed in a foreign country is a class II or class III device?

B. Foreign Country-Related Eligibility Requirements2

What do you need to know about the inspection process of the foreign country or countries where you will market your medical device?

At least one foreign country where you market or intend to market your class II or class III device must either:

For example, one foreign country where you market or intend to market the device may certify the person you selected as an AP as authorized to conduct inspections of device establishments. This would satisfy the condition of recognition by a foreign country of the AP you selected.


2Unless otherwise noted, a reference to “requirements” in the following section refers to the requirements under section 704(g) of the act.

How can you identify APs that are recognized by a foreign country as authorized to conduct inspections of device establishments?

Alternatively, how can you show that a foreign government recognizes device inspections by the FDA or AP?

There are at least three ways to show that a foreign government recognizes device inspections by the FDA or AP:

C. Inspection History

How does your inspection history affect your participation in the AP Program?

What information should I submit concerning my firm's inspectional history?

To facilitate our review of your recent inspectional history, your request to participate in the program should include the following information.

Does an OAI classification from FDA mean that I cannot participate in the AP Program?

D. Accredited Person (AP) Selection

How do you obtain FDA agreement to use an AP?


E. Requests for Participation in the AP Program

Does my request have to be in a particular format?

No. However, your request needs to identify the AP you have chosen and include information that shows you meet the eligibility criteria (sec. 704(g)(6)(A) of the act).

If a foreign country recognizes the AP you selected as a person authorized to conduct inspections of device establishments, you may support your statement to that effect by referring to any relevant information from FDA's websites.3 Alternatively, you may show that the law of the foreign country recognizes an inspection by the FDA or an AP by submitting the documentation discussed earlier in this guidance (e.g., a letter from an appropriate foreign government official).


3This information is available at: www.fda.gov/cdrh/ap-inspection/ap-inspection.html

Will FDA notify you if your application is not complete?

Yes. If FDA needs more information about your firm, its inspectional history, the AP you have chosen, or other eligibility criteria, we will contact you as soon as possible. We intend to respond to each request within 30 days. (Sec 704(g)(6)(B)(i) of the act.)

If FDA does not respond within 30 days after it receives your request, your request is deemed approved, and you may make arrangements for the AP you have selected to inspect your facility. (Sec. 704(g)(6)(B)(i) of the act.)

Where should you send your request to participate?

You should send your request to participate in the AP Program to—

Field Programs Branch (HFZ-306)
Office of Compliance
Center for Devices and Radiological Health
2094 Gaither Road
Rockville, MD 20850.

Does the AP Program affect other FDA agreements and obligations?

Inspections conducted under the AP Program do not affect FDA’s other agreements or operations or change obligations concerning FDA regulations that affect your device. (See generally sec. 704(g)(1), (9), and (14) of the act.)

 

FDA-Accredited Third-Party Inspection Checklist


This checklist may be used to help you determine if you qualify for inspection by an FDA-accredited third party (AP). A GMP inspection of your manufacturing operations may be conducted by an AP, instead of by FDA, provided you meet the following criteria and you obtain FDA approval of your request for participation in the AP Program.

The Devices

1.__ You market a class II or class III device in the United States.

2.__ You market or plan to market a class II or class III device in one or more foreign countries.

Foreign Government

3.__ A foreign government in a country where you market or plan to market a class II or class III device recognizes either:

(a) the AP you have selected as a person authorized to conduct device inspections. Check FDA’s list of APs at http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html, or

(b) an inspection by the FDA or an AP. Ways that you may demonstrate this include—

- Submitting information showing that the foreign government accepts FDA’s Certificates to Foreign Governments or Certificates of Exportability (see the Foreign Liaison List for devices at http://www.fda.gov/cdrh/devadvice/391.html), or
- You have a letter from an appropriate government official that says it recognizes an inspection by FDA or the AP, or
- The foreign country’s laws recognize device inspections by the FDA or an AP, and you submit a written a statement to that effect together with a translated version of the relevant foreign law.

History of Inspection

4.__ Your most recent inspection performed by FDA or by an AP under this program was classified by FDA as either “No Action Indicated” (NAI) or “Voluntary Action Indicated” (VAI).

Updated June 2, 2004

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