FDA Amps Up Postmarket Focus With String of Public Meetings

Devicemakers will have an opportunity to air their concerns about the FDA’s postmarket surveillance system at a Monday public meeting in Greenbelt, Md. The agency is particularly interested in hearing about ways the system could be strengthened to address concerns raised in a 2011 Institute of Medicine report on flaws in the 510(k) premarket clearance procedures. A CDRH report on the center’s plan to bolster device postmarket surveillance will be released in advance of the meeting, the agency said.
Devices & Diagnostics Letter