PwC to U.S. med-device industry: Be prepared

Manufacturers of medical devices “must prepare to respond to the FDA’s new unique device identification (UDI) provisions, which could require serialization not only of finished products but also constituent components. This may require manufacturers to rethink sourcing and supplier monitoring processes.”

Such is the advice of PricewaterhouseCoopers (PWC), the New York City-based accounting giant, as stated in an August newsletter focused on the 2012 Food and Drug Safety and Innovation Act signed into law by President Barack Obama last month. One of the law’s major provisions reauthorized the Medical Device User Fee and Modernization Act according to a money-for-efficiency agreement between FDA and industry reps.  

The PWC publication breaks down the new law’s ramifications for drug makers as well as device manufacturers, summarizing the law’s content and offering general observations without recommending specific actions.

For example, after pointing out that FDA will now be permitted to change devices’ risk classification by administrative order instead of by regulation, PWC suggests that manufacturers “adapt to the FDA’s new autonomy in device classification. Companies should be better prepared to respond in the event of reclassification, which would include maintaining readily accessible safety documentation.”

Elsewhere the newsletter notes that FDA’s move to harmonize its requirements with those of foreign countries represents a significant change for manufacturers to reckon with—and benefit by. “The agency may now use data from outside of the U.S. for device approvals, further reducing the information requirements for global manufacturers,” wrote PWC.   

Produced by PWC’s Health Research Institute, the five-page publication is available as a free download.