Home » FDA Amps Up Postmarket Focus With String of Public Meetings
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
Devices & Diagnostics Letter
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