Many medical device manufacturers do not realize they can save time, money and resources while satisfying inspection requirements by the FDA and other conformity assessment providers. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA introduced the Inspection by Accredited Persons Program or Third-Party Inspection Program. Under this program, eligible Class II and III medical device manufacturers can turn to an FDA-accredited third party to perform U.S. regulatory inspections.
By law, the FDA must inspect Class II and III device manufacturers every two years. But the FDA's internal resources dwindled as the medical device industry expanded globally. As a result, actually completed inspections (especially for lower risk device manufacturers and foreign manufacturers) were much lower than the biannual inspection requirement. Allowing a qualified third-party, such as TUVRheinland, to act as an FDA proxy lightened the inspectors' load while ensuring U.S. regulatory requirements were being met.
For participating manufacturers, the FDA's AP Program offers a tremendous benefit: FDA inspections can be combined with other conformity assessment inspections, e.g. Medical Device Directive, ISO 13485, and CMDCAS. Combining these usually separate inspections saves the manufacturer valuable time, money and resources.
In January 2008, the U.S. Government Accountability Office (GAO) issued a report about the FDA's ability to complete required inspections. In the report, the FDA estimated that facilities for medium risk devices had been inspected every five years in the U.S. and every 27 years abroad. The wide variance underscored the need to start the AP inspection program. Through it, the FDA can focus on inspections deemed "higher-risk" or outside the scope of the program, such as "for cause," pre-market approval, and bioresearch monitoring inspections.
Global manufacturers have been faced with a growing number of regulatory requirements and conformity assessments in other countries. To maintain an international market presence, they must annually undergo separate inspections to demonstrate compliance with multiple regulatory requirements. Thankfully, by participating in the AP Inspection Program, the number of inspections needed to meet FDA and other countries' regulations is reduced. Another benefit is more control to schedule inspections.
pMAP focuses on the common ground shared by both the FDA's AP Program and Health Canada's CMDCAS program. Its purpose: review the effectiveness of a single third-party inspection/audit of a quality management system to satisfy both the U.S. and Canada's regulatory requirements.
Currently, pMAP is mandatory for manufacturers who are seeking a single inspection/audit under the CMDCAS and AP program. pMAP does not alter or eliminate any previously established procedures, guidance and regulations. Ultimately, it is a program in itself, with its own set of rules and requirements.
The FDA and Health Canada's programs involve third-party quality system auditing organizations. Therefore, the two organizations plan to learn how these auditing/inspection approaches support several regulatory objectives at once.
Manufacturers who in the past have not been inspected at two-year intervals might want to consider an AP inspection for another reason: historic data shows that regularly inspected establishments are more likely to be found in compliance with the regulations. Regularly requesting an AP inspection can increase confidence in the manufacturer's quality management system as well as its conformance to U.S. regulations.
Finally, ineligible manufacturers or those not participating in the program are encouraged to voluntarily host joint inspections by the FDA and a Third Party. In fact, any manufacturer who has received FDA notification of due inspection can greatly help advance the AP Program by allowing a third-party auditor to join the next FDA inspection.
Manufacturers who decide to volunteer for joint inspections should contact the FDA and request a joint inspection be conducted by an auditor from their preferred Registrar/Notified Body. Giving your own third-party compliance provider experience in this program has two benefits. First, the training will advance your auditors through the FDA training program. Second, your third-party inspector, once certified by the FDA, will be able to handle your inspections as an FDA proxy in the near future.
Despite the low numbers, both programs are active and operational. Successful audits/inspections have been conducted and plans have been made to continue increasing these numbers. FDA and Health Canada remain committed and have proposed changes and initiatives to promote and advance both of their programs.
However, more participation is required to keep the AP Program and pMAP alive. Consider the overall savings to the bottom line, and it will be an easy decision to proactively seek involvement in these worthy ventures.
Gregor Dzialas is the FDA Third-Party Audit Program Manager and Certification Officer at TUVRheinland's Boxborough, Massachusetts office. Dzialas has 14 years' experience in the medical device industry with an expertise in FDA third-party inspections. He holds degrees in biology from University of Cologne and biomedical engineering from Technical University Giessen-Friedberg.
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