Wanted: More Participants for FDA’s Third-Party InspectionWanted: More Participants for FDA’s Third-Party Inspection

Many device manufacturers can save time, money, and resources while satisfying inspection requirements by FDA and other conformity assessment providers.

Gregor Dzialas

January 1, 2009

10 Min Read
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REGULATORY OUTLOOK


In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number of FDA inspectors to visit every facility on the list.

Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), FDA introduced the Accredited Persons (AP) Inspection Program, or third-party inspection program. The program enables eligible Class II and Class III medical device manufacturers to use an FDA-accredited third party to perform U.S. regulatory inspections. Although the program is voluntary, allowing qualified third parties to handle the inspection as an FDA proxy is designed to lighten the agency's load while ensuring that U.S. regulatory requirements are being met.

FDA's AP program offers a tremendous benefit to participating manufacturers, because they can combine FDA inspections with other conformity assessment inspections, such as those required by the Medical Devices Directive or by ISO 13485. Combined inspections allow manufacturers to recover lost time, money, and resources.

Inspection via an AP

By law, FDA must inspect Class II and Class III device manufacturers every two years. However, FDA's internal resources began to dwindle as the medical device industry expanded globally. As a result, completed inspections, especially for low-risk device manufacturers and foreign manufacturers, were less frequent than the biennial inspection requirement.

The passage of MDUFMA established a new subsection of the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), which required FDA to accredit qualified third parties to perform inspections of eligible device manufacturers. Through this program, an AP is a third party recognized by FDA to:

  • Assess the quality system of eligible manufacturers of Class II and Class III devices under 21 CFR Part 820.

  • Determine compliance with other device requirements in the FD&C Act.

  • Prepare and submit reports to FDA, after which the agency makes the final compliance assessment.

Gregor Dzialas

In January 2008, the U.S. Government Accountability Office (GAO) issued a report about FDA's ability to complete required inspections. In the report, FDA estimated that facilities for medium-risk devices had been inspected every five years in the United States and every 27 years abroad. The wide variance underscored the need for the AP inspection program. Through it, FDA can focus on high-risk inspections as well as those outside the scope of the program, such as for-cause, premarket approval, and bioresearch monitoring.

Despite FDA's struggle to hold biennial inspections, global manufacturers have been faced with growing regulatory requirements and conformity assessments. To maintain their market presence in other countries, they must undergo numerous separate inspections each year to demonstrate compliance with requirements that are largely harmonized. Overall, participation in the AP program reduces the number of inspections needed to meet FDA and other countries' regulations. It also controls the scheduling of inspections.

The Multipurpose Audit

The United States is not the first country to turn to third-party compliance experts as a resource. Health Canada launched the Canadian Medical Devices Conformity Assessment System (CMDCAS) several years before FDA started the AP Inspection Program. However, FDA's program touted the ability to perform joint audits for both U.S. and Canadian regulations. To validate the combined audit approach, Health Canada launched a Pilot Multipurpose Audit Program (PMAP) in cooperation with FDA in September 2006.

Table I. (click to enlarge) A simplified audit plan for multipurpose inspections or audits.

PMAP focuses on the common ground shared by FDA's AP program and Health Canada's CMDCAS program. Its purpose is to review the effectiveness of a single third-party inspection or audit of a quality management system to satisfy the regulatory requirements of both countries (see Table I). Both of these regulatory programs already involve third-party quality system auditing organizations. As a result, FDA and Health Canada intend to use PMAP as an opportunity to learn how auditing and inspection approaches can support several regulatory objectives.

It is important to note that at the current time, PMAP is mandatory for manufacturers that are seeking a single inspection or audit under the CMDCAS and AP programs. PMAP does not alter or eliminate any previously established procedures, guidance, and regulations. Ultimately, it is a program with its own set of rules and requirements.

Reasons for Low Adoption

According to a GAO report, both the AP Inspection Program and PMAP have had low participation among medical device manufacturers. From March 11, 2004 (the date on which FDA first cleared accredited organizations to conduct independent inspections), through January 2008, only five inspections were conducted under the AP program and two audits under PMAP. These numbers suggest limited interest, but a closer look at each program's history and rules reveal other reasons for the small numbers.

By October 2003, FDA met its objective to initially accredit 15 third-party inspection services. In the following years, another inspection service was added to that list. Yet, slow progress was made to qualify individual inspectors or auditors. Today, only eight of the 16 accredited third parties are operational and offer independent inspections. Of those eight APs, four are located in the United States.

Each auditor must follow current program rules by participating in three joint inspections with FDA. The demand for joint inspections far exceeds the number of inspections offered. In fact, FDA assigns the inspections to APs by a random draw, which can decrease the odds of fulfilling the required number of joint inspections.

Also working against the third parties has been the lack of training opportunities. Joint inspections depend on device manufacturers volunteering as hosts, but few OEMs choose to do so. Additionally, training has been limited by the availability of FDA performance inspectors who must monitor AP auditors during joint inspections. The limited availability has made it difficult for APs to plan auditor qualifications, which has subsequently affected FDA's ability to offer third-party inspections.

Another reason for low participation in the program might be the restrictive eligibility requirements. For example, certain device manufacturers are excluded from participating. These include those that have not been inspected by FDA (baseline inspection) and those for which the last inspection has been qualified as Official Action Indicated.

In addition, the AP must be recognized by the country in which the manufacturer intends to market a device. A quick view of FDA's Web site shows that some APs appear to be recognized in just a few countries. In one instance, an AP listed on FDA's Web site is recognized only in Norway.

Further, PMAP has outlined an even narrower list of eligibility requirements for manufacturers. Audits not accepted for PMAP include the following:

  • Initial ISO 13485:2003 registration audits under CMDCAS.

  • Transfer of registration from one audit organization to another.

  • Audits to support an extension to the existing scope of registration.

  • Special for-cause audits (i.e., re­audits to follow up on major nonconformities).

Finally, these programs are designed so that device manufacturers can clearly see the benefits and advantages to taking part in the program. However, participation appears to require a mind-set adjustment regarding how to deal with FDA inspections and procedures.

For example, manufacturers that want to market products in Canada and in the European Union must invite CMDCAS registrars and notified bodies for an initial certification audit and surveillance audits at an annual interval. In the United States, this approach has not been the standard, because premarket approval or premarket notification clearance is all that is needed to market a product. FDA decides which manufacturers to inspect and at what frequency, and has been using a risk-based approach for these decisions.

The AP program asks the manufacturer to assume a strong role in facility compliance. The OEM can request its registrar, once qualified by FDA, to handle the inspection. Taking this approach further ensures that the manufacturer stays in compliance, and that any potential failures in the facility are revealed early. Other benefits to this approach include a reduced workload and lower costs, as well as more control over the planning of the audit.

Pushing Manufacturer Participation

After realizing the challenges of the AP program, FDA and Health Canada have worked on improving manufacturer participation. Legislative recommendations for MDUFMA II, which were made last April, include proposals for the following changes:

  • Streamline administrative burdens. Firms must provide FDA with 30 days notice of their intent to use an AP. This is a change from petitioning FDA for clearance to use an AP.

  • Expand participation. Firms may use an AP for an unlimited number of consecutive inspections without seeking a waiver. An AP was previously used for only two consecutive inspections. FDA will continue to conduct for-cause or follow-up inspections at its discretion. The industry will be encouraged to provide the agency with more data about the products and facilities.

  • Offer the option of submitting a recent ISO report. Firms may voluntarily submit third-party ISO reports that already confirm conformance with appropriate international quality systems standards. FDA inspectors would consider information from this report as they set inspectional priorities. However, the caveat is that this option is still in an early stage, and FDA is working on guidance for this piece of legislation.

Health Canada and FDA have worked together to identify all U.S. device manufacturers that are due for an inspection in 2008. They also identified which of these manufacturers are registered to ISO 13485 under the ­CMDCAS program. Manufacturers that met both criteria received information in the mail about PMAP and were encouraged to participate.

Most recently, there has been a surge of interest in the program. In a Health Canada CMDCAS Registration Body Forum meeting last May, it was announced that five companies had already been successfully assessed under PMAP. Both Health Canada and FDA expressed their continued commitment to the program, and they decided that 10 successful PMAP audits would be sufficient experience to assess the results of the pilot. Ultimately, some of the restrictions might be eliminated if the assessment shows that multipurpose audits are valid and fulfill the requirements under the CMDCAS program.

Another very promising objective that arose from this meeting was the development of a common audit and inspection report format. A common report format would significantly reduce the time needed by an AP or registrar to prepare the two submissions. This time savings would reduce the additional service fees associated with AP or PMAP audits.

Who Should Participate and Why

Manufacturers that are likely to be inspected by FDA and that market products in foreign countries benefit from participation in PMAP and the AP program because it reduces the overall number of audits or inspections conducted. They will also gain more control over its timing and planning.

If manufacturers haven't been inspected at two-year intervals, they might consider an AP inspection for another reason. Historic data show that regularly inspected establishments are more likely to be found in compliance. Requesting an AP inspection can increase confidence in the manufacturer's quality management system as well as its conformance to regulations.

Those not currently eligible under or participating in the program are encouraged to voluntarily host joint inspections by FDA and a third party. In particular, manufacturers that have received FDA notification that they are due for an inspection can greatly help to advance this program by allowing a third-party auditor to join in on their next FDA inspection.

Upon making the decision to volunteer for joint inspections, manufacturers should contact FDA to request that the inspection be conducted by an auditor from their own registrar or notified body. This ensures that the notified body or registrar will advance their auditors through the training program and be able to offer independent inspections to their clients in the future.

The Future of Third-Party Inspection Programs

Both the AP program and PMAP are active and operational. Successful audits or inspections have been conducted under both programs, and plans have been made to continue expanding these numbers. FDA and Health Canada remain committed and have proposed changes and initiatives to promote and advance both programs. However, more participation is required to keep these programs alive.

Gregor Dzialas is program manager and certification officer of the FDA Third-Party Audit program at TÜV Rheinland of North America Inc. (Boxborough, MA). Contact him at [email protected].

Copyright ©2009 Medical Device & Diagnostic Industry

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