Dispute Resolution Guidance Flouts FDAMA And Favors CDRH, HIMA Says
This article was originally published in The Gray Sheet
Executive Summary
The draft guidance on scientific dispute resolution recently issued by the Center for Devices and Radiological Health places too much "gatekeeping" authority in the hands of device center officials, the Health Industry Manufacturers Association maintains in comments submitted to FDA July 19.
You may also be interested in...
ODE Adding Third Deputy Director; Feigal Outlines CDRH Ombudsman Role
The Center for Devices and Radiological Health's next Office of Device Evaluation Director will possess a medical degree, CDRH Director David Feigal said in a Nov. 9 interview with "The Gray Sheet."
ODE Adding Third Deputy Director; Feigal Outlines CDRH Ombudsman Role
The Center for Devices and Radiological Health's next Office of Device Evaluation Director will possess a medical degree, CDRH Director David Feigal said in a Nov. 9 interview with "The Gray Sheet."
Dispute Resolution Panel Plans Solidify As CDRH Weighs Industry Comments
FDA intends to publish a Federal Register notice within the next three weeks seeking applicants to fill three standing voting positions on its Medical Devices Dispute Resolution Panel, as well as one industry and one consumer representative, according to FDA staffers.