FDA Seeks Medical Device Inspection Coordination With Other Countries

U.S. health regulators indicate that they want to coordinate with a number of different countries to streamline medical device inspections for products that move across borders. 

The FDA and regulatory agencies in Australia, Brazil, Canada, and Japan are testing out a Medical Device Single Audit Program (MDSAP), which seeks to create a process where one inspection meets the needs of all five countries.

The pilot program began last year, and on January 1, manufacturers were invited to participate in the process, according to an FDA Voice blog post from the agency’s Associated Director of International Affairs, Kim Trautman.

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“Under this pilot, audits will be conducted by recognized third-party organizations, and medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions,” Trautman wrote. “Not only does this program reduce the participating regulators’ need to individually perform routine inspections; it allows them to have the same reliable information about inspectional findings.”

The FDA will allow the audits to count as a substitute for FDA inspections, which are supposed to occur every two years for facilities outside the U.S. However, pre-approval inspections for devices under premarket approval consideration will still have to be done by the FDA.

Keeping up with the inspection of a global medical device manufacturing market has been a struggle for the FDA, which has limited funding for inspection operations. Manufacturing facilities in foreign countries can go for years without inspections due to the limited budget and limited number of inspectors.

The program allows the FDA to hand over those costs to third-party auditors and share remaining costs with multiple countries.

The inspections can also be a struggle for plant operators, since they may have to undergo multiple inspections from multiple countries if they ship their products internationally. Those countries may also have different, and sometimes conflicting, manufacturing requirements.

Trautman says MDSAP is expected to cut down on the number of regulatory audits those plants must host, and will also help standardize some regulatory processes. In addition, manufacturers who participate now will help shape what the program ultimately looks like.

“Manufacturers that choose to participate in the pilot program will help to shape the policies and procedures of the fully operational MDSAP, which is scheduled to begin in 2017,” Trautman wrote. “We expect that the MDSAP pilot will enhance confidence in third party audit programs, increasing the footprint of this global endeavor.”


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