The FDA yesterday detailed a plan to overhaul procedures at its medical device arm, the Center for Devices & Radiological Health, based on recommendations from an outside auditor’s report last year.
By Dr. Jeffrey Shuren
FDA’s Center for Devices & Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access to medical devices that treat often life-threatening conditions. It’s also important for industry’s ability to continue developing new products.
The FDA needs to make some quality and consistency improvements to meet the promises it made during the latest round of medtech user fee negotiations, according to a team of Booz Allen Hamilton consultants evaluating the FDA’s medical device regulatory review program.