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CDRH Releases Report on Medical Device Postmarket Surveillance




The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released a preliminary report entitled “Strengthening Our National System for Medical Device Postmarket Surveillance.” The report, which provides an overview of FDA’s medical device postmarket authorities and the current U.S. medical device postmarket surveillance system, proposes four specific actions, using existing resources and under current authorities, to strengthen the medical device postmarket surveillance system in the United States.

The CDRH was created to assure that patients and providers have timely and continued access to safe, effective, high-quality medical devices and safe radiation-emitting products; provide consumers, patients, their caregivers and providers with understandable and accessible science-based information about the products it oversees; and facilitate medical device innovation by advancing regulatory science, provide industry with predictable, consistent, transparent, and efficient regulatory pathways, and assure consumer confidence in devices marketed in the United States.

“We believe that strengthening our National Medical Device Surveillance System will complement the improvements we have made to our premarket program,” reads the report. “A medical device postmarket surveillance system should quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance, including the clinical benefits and risks of marketed devices, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.”

This report follows closely on the heels of the proposed plan for unique device identifiers (UDIs) and a plan proposing criteria for better determining the completeness of 510(k) clearance applications. These rapid-fire improvements and changes FDA is making are a result of the passage of the latest version of the Medical Device User Fee & Modernization Act by federal lawmakers. The agency promised to speed up review processes in exchange for the hiked user fees companies would be paying.

“A key part of this mission,” FDA writes on its website, “is to monitor medical devices and radiological products for continued safety and effectiveness after they are in use and to help the public get the accurate, science-based information they need to improve their health.”

The four key points the latest report touches on are: The UDI plan; promoting the development of national and international device registries for selected products; modernizing adverse event reporting and analysis; and developing and using new methods for evidence generation, synthesis and appraisal.






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