Posted byOrthoEx Posted in
Posted on Aug 17, 2018

17 August 2018 | By Ana Mulero 

In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.

The five-pronged action plan—revealed in April—consists of establishing a medical device safety net, exploring regulatory options for postmarket mitigations, spurring innovation towards safer devices and further strengthening cybersecurity.

It also involves plans for a major structural reorganization at FDA’s Center for Devices and Radiological Health (CDRH), which is expected to have an impact on the regulatory reviews, approvals and clearances of devices, to better support the total product life cycle.

The trade association expressed concerns with implying that devices cleared via the expanded abbreviated 510(k) program are safer compared to the traditional 510(k) pathway, whereas Johnson & Johnson expressed support for expanding the alternative to more moderate-risk devices.

The company also further stressed the trade association’s concerns around FDA’s statement that “the marketplace…does not provide strong incentives to make an established device safer in the absence of a new or greater-than-previously-understood safety concern.

“FDA should identify and overcome whatever internal obstacles prevent efficient practice,” said AdvaMed associate VP for technology and regulatory affairs Zachary Rothstein. “We note that at the time of this submission, our members’ experience indicates that FDA’s current use of emerging signals is subjective and, at times, lacks appropriate input from the manufacturer.”

But CDRH’s reorganization plans and advancing the use of RWE in support of regulatory decision-making were both endorsed by AdvaMed. The center’s RWE efforts, as well as those around advancing cybersecurity, are centered on developing the National Evaluation System for Health Technology, which is run by the nonprofit Medical Device Innovation Consortium (MDIC).