The FDA's medtech arm is looking for volunteers to pilot its electronic 510(k) application submission software, starting with cardiovascular devices/diagnostics and peripheral intervention devices.
U.S. medical device regulators are looking for volunteers to test out a software-based version of its 510(k) submission program, an alternative to submissions that traditionally require paper copies or compact discs.
The new "CDRH 510(k) eSubmissions Pilot Program" will guide users through creating and submitting a 510(k) medical device review application electronically. The FDA is hoping a few guinea pigs will volunteer to run the course and provide feedback.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1hSUxF2
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