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).
AdvaMed also discussed the potential need of new legal authorities for FDA to pursue the proposed efforts relating to imposing special controls through a new umbrella regulation and a “Software Bill of Materials” as an additional requirement for device premarket submissions.
On FDA’s plan to consider implementing a CyberMed Safety Analysis Board (CYMSAB), the group cautioned against having this board be “a separate or parallel regulator” due to the confidential nature of the information its work would entail and said industry would be supportive if its purpose would be to serve as an advisory committee for policy recommendations.
The “plan’s suggestion that the CYMSAB would ‘deploy’ to investigate suspected security compromises” is of concern to AdvaMed and its “makeup, selection, authority, training and expertise is not clear, and the notion that it would be granted power to inspect or investigate real world vulnerability events and make decisions requires further discussion,” Rothstein added.
The comment period on the Medical Device Safety Action Plan closed Friday with 14 submissions, including one from Johnson & Johnson that echoed AdvaMed’s comments.
Johnson & Johnson’s and AdvaMed’s comments differed, however, in their views on a new alternative
for demonstrating substantial equivalence to existing devices through objective performance criteria, which have yet to be identified by FDA, to obtain 510(k) clearance.
Medical Device Safety Action Plan