DrBicuspid

FDA targets improvements to 510(k) process

With an eye toward encouraging innovation, providing regulatory predictability, and ensuring patient safety, the FDA's Center for Devices and Radiological Health (CDRH) has issued two preliminary ...
MD&M East

4 Tips for a Smooth 510(k) Submission Process

An expert shares four things he's learned about the 510(k) submission process that you can use to your advantage. Jon Speer As you are probably aware, a 510(k) submission is required in order to get ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

At the request of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices. 2 Also known as ...