Contains Nonbinding Recommendations
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
Document issued on: [Insert release date of FR Notice]
This document supersedes “Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties” issued on April 28, 2003
The information collection provisions in this guidance have been approved under OMB control number 0910-0510. This approval expires 11/30/2006. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
For questions regarding this document contact John F. Stigi, Center for Devices and Radiological Health (CDRH) at 301-443-6597 ext. 124, or by e-mail at: . For questions regarding the application of this guidance to devices regulated by the Center for Biologics Evaluation and Research (CBER) contact Carol Rehkopf at 301-827-6202 or by e-mail at: .
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biological Evaluation and Research
Third Party Implementation Team
Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to Docket No. 03D-0117. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
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TABLE OF CONTENTS
I. What is the Purpose of this Guidance?
II. Introduction
A. Why Are Medical Device Establishments Subject to Mandatory Inspections? 7
B. What is the Quality System /Good Manufacturing Practice (GMP) Regulation? 7
C. What is FDA’s Experience with Third Party Quality System Inspections? 8
D. How Does the Medical Device User Fee and Modernization Act of 2002 Affect FDA Inspections? 9
III. What is the Inspection by Accredited Persons (AP) Program?
A. What Are the Primary Features of the Program? 9
B. What Establishments Are Eligible for Inspection by APs? 10
C. How Do I Request an Inspection by an AP? 10
D. What Can I Do if FDA Denies My Request to Use an AP? 11
E. Are There Limits to the Number Of AP Inspections that can be Performed? 12
F. How Can I Become an AP? 12
G. What Qualifications Are Necessary to Become an AP? 13
H. If I Am Approved as an AP, what Training will be Required Before I Can Do
Inspections? 17
I. How Will APs be Monitored? 18
J. How Will FDA Address Concerns about the Independence of APs? 19
K. What Inspection Records are to be Submitted to FDA? 19
L. How Will AP’s and FDA Treat Confidential Information? 20
M. What Records Should an AP Maintain? 21
N. What Fees May an AP Assess? 21
O. Can FDA Withdraw AP Accreditation? 22
P. Did MDUFMA Change the Prohibited Acts Section of the act? 22
Q. How do Manufacturers Identify an AP? 22
IV. What is the Format and Content of an AP’s Initial Application?
A. How Will FDA Evaluate the AP Application? 22
B. What Are the Contents of an AP Application? 23
1. Administrative Information 23
2. Prevention of Conflict of Interest 25
3. Technical Competence 25
4. Resources 26
5. Confidentiality 27
6. Contractors 27
7. AP Quality System 28
8. Certification Agreement Statement 28
C. Where Do I Send an Application to Become an AP? 29
D. Can I Request Reconsideration of a TPRB Decision? 29
V. How Can I Obtain Additional Information?
Appendices:
These documents are available on the FDA and CDRH Home Pages in text or PDF versions. The URL’s are included in Section V of this guidance.
- Standards of Ethical Conduct for Employees of the Executive Branch
- Model Conflict of Interest (COI) Policy
- Rating Criteria Checklist (Checklist)
- The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.)
- The Public Health Service Act (42 U.S.C. 201 et seq.)
- Title 21, Code of Federal Regulations, Parts 1-1271
- FDA Compliance Program 7382.845, Inspection of Medical Device Manufacturers
- Investigations Operations Manual
- Guide to Inspections of Quality Systems (Quality System Inspection Technique)
- Guidelines for the Regulatory Auditing of Quality Systems for Medical Device Manufacturers – Global Harmonization Task Force (GHTF) SG-4 (99) 28
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
This guidance represents 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. What is the Purpose of this Guidance?
This guidance is intended to implement new section 704(g) of the Federal Food, Drug, and Cosmetic Act (FDCA or the act) by accrediting third parties (Accredited Persons) to conduct inspections of eligible manufacturers of Class II and Class III medical devices. Inspections by Accredited Persons will be conducted in essentially the same manner as those conducted by FDA. The Inspection by Accredited Persons Program will be conducted independent of third party inspections performed under the U.S./EC Mutual Recognition Agreement (MRA), http://www.fda.gov/cdrh/mra/introduction.html, currently in progress. However, some features of the two programs will be similar.
The Inspection by Accredited Persons Program will provide manufacturers an alternative to the traditional inspection by an FDA official. At the same time, it will allow FDA to utilize its inspectional resources in a more flexible manner.
This guidance provides information for those who are interested in the new program (Inspections by Accredited Persons), including:
· Persons who seek to be accredited to perform Quality System (QS) / Good Manufacturing Practice (GMP) inspections under the Federal Food, Drug and Cosmetic Act (the act);
· Medical device establishments subject to inspection under section 704 of the act; and
· FDA staff responsible for implementing the program.
For purposes of this guidance, an Accredited Person (AP) is a third party recognized by FDA to:
· perform the equivalent of an FDA Quality System inspection of eligible manufacturers of Class II and III devices under 21 CFR Part 820 and
· prepare and submit reports to FDA, who makes the final compliance assessment.
Note: Although this guidance provides a general outline of the elements of the program that apply to establishments who may wish to use a third party inspector, the focus of this document is on third parties who want to apply to become APs under this program. “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,” available at http://www.fda.gov/cdrh/comp/guidance/1532.pdf, provides establishments with more information about procedures for participating in this program.
This guidance represents the Agency's current thinking on the implementation of the Inspection by Accredited Persons Program under MDUFMA. MDUFMA requires FDA to "publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform" inspections of eligible manufacturers of Class II and Class III medical devices in lieu of FDA inspection. (Section 704(g)(2)). These criteria were published in the Federal Register on April 28, 2003 at 68 FR 22400. On [insert date] FDA published revised accreditation criteria in the Federal Register [insert FR cite] to incorporate changes to MDUFMA made by the Medical Devices Technical Corrections Act (MDTCA)(Public Law 108-214) which was signed into law on April 1, 2004. The published criteria are binding on those persons who apply to become APs under this program.
The criteria for APs that FDA published in the Federal Register are repeated in this guidance, as well as additional information that will assist with the implementation of this new program. Although guidances are generally non-binding and should be viewed only as the agency's recommendations, the portions of this document that repeat the criteria FDA will use to select APs (see sections III.G-H, and IV.A-B below) have binding effect; therefore, the standard language that generally appears in FDA guidances stating that such documents constitute mere recommendations does not apply to these portions. However, with respect to the remainder of this document, the following standard language still applies:
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.
The Least Burdensome Approach
The issues identified in this guidance document represent those that FDA believes need to be addressed by participants in this program. In developing the guidance, FDA carefully considered the relevant statutory criteria. FDA also considered the burden that may be incurred in complying with the guidance and addressing the issues we have identified. FDA believes that we have considered the least burdensome approach to resolving the issues presented in this guidance document. If, however, you believe that there is a less burdensome way to address the issues, please contact us. You may send your comments to the contact person listed in the preface of this guidance. Also, comprehensive information on dispute resolution at Center for Devices and Radiological Health (CDRH) is listed on the CDRH Ombudsman’s web page: http://www.fda.gov/cdrh/ombudsman/. Information on dispute resolution for Center for Biologics Evaluation and Research (CBER) regulated devices is listed on the CBER web site at: http://www.fda.gov/cber/inside/ombudsman.htm
II. Introduction
A. Why Are Medical Device Establishments Subject to Mandatory Inspections?
The FDCA established a requirement that FDA inspect manufacturers of Class II and III devices at least once every two years because Congress believed regular oversight would help ensure that appropriate manufacturing conditions and controls were in place to produce safe and effective products [see Section 510(h) of the FDCA]. The agency’s ability to perform biennial inspections of all eligible establishments has diminished with decreasing resources and the significant growth of the medical device industry. Over the years, the agency has reengineered its inspection policy and work plans to embrace a risk based approach that targets limited resources to inspections that will best protect the public health. The AP inspection program established by MDUFMA will be another tool the agency and stakeholders can use to leverage resources by permitting qualified independent third parties to perform certain biennial inspections.
B. What is the Quality System / Good Manufacturing Practice (GMP) Regulation?
The GMP requirements for medical devices were first authorized by the Medical Device Amendments of 1976 in section 520(f) of the act. As a result of this new authority to inspect medical device facilities, FDA published final regulations in July 1978, prescribing GMP requirements for the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of medical devices. This regulation became effective in December 1978 and was codified in Title 21 of the Code of Federal Regulations, Part 820 (21 CFR Part 820).
In developing the 1978 GMP regulation, FDA recognized that the medical device industry consists of manufacturers whose devices and manufacturing processes differ significantly. Therefore, the GMP regulation was designed to specify general requirements in areas of concern applicable to all manufacturers. Under the GMP regulation, FDA expects each manufacturer to develop a set of appropriate procedures for the manufacture of each device. FDA conducts inspections and evaluates these procedures to determine whether the manufacturer is complying with the regulation.
In November 1990, the Safe Medical Devices Act (SMDA) amended section 520(f) of the act to give FDA the authority to add preproduction design controls to the GMP regulation. The SMDA also added a new section 803 to the act. This section encourages FDA to work with foreign countries toward mutual recognition of the GMP and other regulations. This section also encourages any revision of the GMP regulation to be consistent with the requirements contained in applicable international standards.
In October 1996, FDA published the Quality System regulation (QS regulation), which revised the 1978 GMP regulation, incorporating new requirements for preproduction design controls, supplier and service controls, and management controls. As part of this process, FDA attempted, to the extent possible, to harmonize the QS regulation with the international standard ISO 13485:1996, Quality Systems, Medical Devices, Supplementary Requirements to ISO 9001:1994.
C. What is FDA’s Experience with Third Party Quality System Inspections?
U.S./EC Mutual Recognition Agreement
On June 20, 1997, the United States (U.S.) and the European Community (EC) signed a Mutual Recognition Agreement (MRA) which covers a variety of product sectors, including medical devices. The aim of this agreement is to facilitate transatlantic trade while reducing costs for compliance with regulatory requirements. This agreement became effective December 1, 1998 and initiated a three-year transition period during which time both sides have engaged in confidence-building activities. The confidence-building period was extended to December 2003.