Radiology Business September 10, 2023
The U.S. Food and Drug Administration announced Sept. 6 that it is hoping to modernize the premarket notification 510(k) program that many radiology devices must go through.
As part of the process, the agency released three draft guidance documents, aimed at supporting efforts to strengthen the process. They cover topics including best practices for premarket submission, recommendations on the use of clinical data, and evidentiary expectations for implant devices.
“We recognize there is a need to continue to modernize the 510(k) Program to improve the safety of medical devices while...
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