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The information collection provisions in this guidance have been approved under OMB control number 0910-0569. This approval expires August 31, 2008. 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 Casper Uldriks, 240-276-0106, ceu@cdrh.fda.gov, for CDRH issues or Carol Rehkopf, 301-827-6202, Rehkoph@cber.fda.gov, for CBER issues.
U.S. Department
of Health and Human Services Center for Devices and Radiological Health |
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. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/comp/guidance/1532.pdf. or to receive this document by fax, 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.
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. |
On October 26, 2002, Section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) amended section 704 of the Federal Food, Drug, and Cosmetic Act (the act) by adding subsection (g). (21 U.S.C. 374(g)). Certain important technical corrections were later made to section 704(g) by the Medical Devices Technical Corrections Act of 2004 (MDTCA)(Public Law 108-214), which became law on April 1, 2004. Section 201 of MDUFMA, as amended by MDTCA, authorized 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. These 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 eligible 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. Most of the APs who have been approved by FDA will have to complete training before they may begin conducting independent inspections under the new program. Therefore, many of 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.
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.
Under section 510(h) of 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)). The AP inspection program established by MDUFMA permits eligible manufacturers to schedule qualified independent third-parties to perform a comprehensive inspection that satisfies FDA’s biennial inspection requirement, provided the previous completed FDA or AP inspection resulted in a “No Action Indicated” (NAI) or “Voluntary Action Indicated” (VAI) inspection. Manufacturers customarily schedule a series of partial inspections to be performed by qualified independent third-parties to comply with international and other national regulatory standards. Manufacturers may rely on a single comprehensive inspection or a series of partial inspections that would cumulatively constitute a complete inspection for the purposes of meeting FDA’s biennial inspection requirement.
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. Most of those APs who were selected are still in the process of completing training so they may soon begin conducting independent inspections under the AP Program. Once independent AP inspections are underway, FDA will review the reports prepared by the APs 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#list. 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.
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.
Based on the 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:
The following are examples of ways you can show that you market or intend to market a device in a foreign country:
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.
There are at least three ways to show that the law of a foreign government recognizes device inspections by the FDA or AP:
To facilitate our review of your recent inspectional history, your request to participate in the program should include the following information.
MDUFMA sets limits on the number of consecutive completed inspections that can be performed by APs in lieu of FDA inspections. APs may perform a series of partial inspections that cumulatively would count as one complete inspection. Section 704(g)(6)(A)(iv)(I) of the act does not permit an establishment to use an AP for more than four years to conduct two consecutive complete inspections unless the establishment first petitions FDA for, and receives, a waiver.(4)
No. The same AP may conduct partial inspections that ultimately will represent one completed comprehensive inspection for purposes of complying with applicable regulatory requirements. In this situation, the two year period begins at the time the first partial inspection is initiated.
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 website at www.fda.gov/cdrh/ap-inspection/ap-inspection.html. 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).
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.)
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
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.)
This checklist may be used to help you determine whether 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.
1 The phrase "complete inspection" as used in this document is intended to include situations in which a full inspection may be comprised of two or more cumulative partial inspections performed by the AP during the course of a two year period. Where an inspection consists of a series of partial inspections, FDA ordinarily would expect to issue only one classification decision after the conclusion of the complete inspection. (Return)
2 Unless otherwise noted, a reference to “requirements” in the following section refers to the requirements under section 704(g) of the act. (Return)
3 Unless otherwise noted, a reference to “requirements” in the following section refers to the requirements under section 704(g) of the act. (Return)
4 The statute describes the applicable time limits using the words “during the previous four years.” (Section 704(g)(6)(A)(iv)(I) of the act.) FDA reads “during” to mean “throughout the course or duration of,” as cited in Webster’s II New Riverside University Dictionary, 1984 edition. (Return)
Updated September 15, 2005
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