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market access Medical Reprinted with permission from Medical Device & Diagnostic Industry, “Wanted: More Participants for FDA’s Third-Party Inspection,” January 2009. Copyright © 2009 Canon Communications LLC. 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. Traditionally, the FDA handled all inspections of manufacturing facilities. But as U.S. manufacturers began to expand nationally and globally, the increasing numbers made it difficult for the limited number of FDA inspectors on hand to visit every facility on the list. Allowing a qualified third-party, such as TÜVRheinland ® , to handle the inspection as an FDA proxy loosened the load while ensuring U.S. regulatory requirements were being met. maY/09/juNe 10 What is the FDA’s Third Party Inspection Program and pMAP? pMAP Reduces Number of Audits/Inspections; Provides More Control Over Timing and Planning of Audits/Inspections Authored by gregor dzialas, Third-Party Inspection Program Manager (Boxborough, MA) ConTInUEd on PAgE 11 On the upside, the FDA’s AP Program offers a tremendous benefit to participating manufacturers. Manufacturers can combine FDA inspections with other conformity assessment inspections, e.g., MDD/ISO 13485/CMDCAS. Combining these usually separate inspections into one, allows the manufacturer to uncover once lost time, money and resources. a Closer look at mdUFma When the MDUFMA of 2002 was passed, it established a new subsection of the U.S. Food, Drug and Cosmetics Act, which required the FDA to accredit qualified third parties to perform inspections of eligible device manufacturers. Through this program, an Accredited Person (AP) is a third party recognized by FDA to: • Assess the quality system of eligible manufacturers of Class II and III devices under 21 CFR Part 820. • Determine compliance with other device requirements in the act and regulations. • Prepare and submit reports to FDA, which makes the final compliance assessment. 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.
market access Medical 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 higher-risk inspections as well as those outside the scope of the program, such as “for cause,” pre-market approval, and bioresearch monitoring inspections. In spite of the FDA’s struggle to hold biennial inspections, global manufacturers have been faced with a growing number of regulatory requirements and conformity assessments in other countries. 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 Inspection Program reduces the number of inspections needed to meet FDA and other countries’ regulations, and to control the scheduling of inspections. two for one: the Pilot multi-Purpose audit Program The U.S. is not the first country to turn to third-party compliance experts as a resource. Health Canada originally launched CMDCAS several years before the FDA started the AP Inspection Program. However, the 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 Multi-Purpose Audit Program in cooperation with the FDA in September 2006. pMAP focuses on the common ground shared by both the FDA’s AP Program and Health Canada’s CMDCAS program. Its purpose is to 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. Both of these regulatory maY/09/juNe 11 What is the FDA’s Third Party Inspection Program and pMAP? (continued) ConTInUEd on PAgE 12 programs already involve third-party quality system auditing organizations. As a result, the FDA and Health Canada intend to use pMAP as an opportunity to learn how auditing/inspection approaches can support several regulatory objectives at once. It is important to note that at the current time, the 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. Progress and status of the aP and pmaP Programs 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 the 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 the pMAP. These numbers suggest a limited interest in these programs
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