FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report

 
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report (Bloomberg)
A program allowing U.S. regulators to approve moderate-risk medical devices in an average of 10 months instead of years shouldn’t be scrapped, the Food and Drug Administration said in response to an advisory panel report.
The Institute of Medicine, asked by the agency to review the program, urged the FDA today to abandon use of the so-called 510(k) process to clear a class of devices that include orthopedic implants and x-ray machines. The system is used to evaluate products similar to those already clear...


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