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Medical Device Manufacturers Invited to Participate in Pilot to Streamline Audits

Thursday, January 22, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration reports that effective Jan. 1 manufacturers around the world interested in marketing medical devices in Australia, Brazil, Canada and the U.S. were invited to participate in a pilot program designed to streamline the process of ensuring the safety of imported medical devices. The same invitation is expected to be issued this summer to medical device manufacturers interested in marketing in Japan.

According to the FDA, the Medical Device Single Audit Program pilot was launched on Jan. 1, 2014, to develop a process that allows a single audit or inspection to ensure that the medical device regulatory requirements for all five countries are satisfied in an efficient yet thorough manner. Under this pilot, audits will be conducted by recognized third-party organizations and medical device regulators in participating countries will be able to use these inspection reports when making regulatory decisions. This form of international and standardized oversight reduces the number of routine audits and inspections that must be performed, the FDA notes, which benefits both regulators and manufacturers. The pilot also does not increase regulatory requirements for medical device manufacturers, as the audits cover only the existing requirements of the participating regulatory authorities.

The FDA states that it will accept MDSAP audits as a substitute for routine FDA inspections, which are typically done every two years for all classes of medical devices, including in vitro diagnostic devices. However, pre-approval inspections for devices requiring premarket approval applications and “for cause” compliance inspections will not be part of the MDSAP pilot.

Manufacturers that choose to participate in the pilot program will help shape the policies and procedures of the fully operational MDSAP, the FDA adds, which is scheduled to begin in 2017.

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