Wednesday, February 24, 2010 1:37 AM
Will FDA Scrap the 510(k)?
Last week, the U.S. Food & Drug Administration's expedited device approval process—known as the 510(k) clearance program—faced severe criticism from some heavy hitters ranging from Senator Charles Grassley, to wide sections of the public, and the agency itself.
In the day-long public hearing convened on February 18, 2010, the FDA invited comments from a variety of stakeholders on its 510(k) clearance program for medical devices. The program, by which the vast majority of medical devices are approved by the FDA, relies on previous approvals of similar or "predicate" devices. At the hearing, Diana Zuckerman, president of the National Research Center for Women & Families, said the 510(k) process has "major problems" requiring "major impr more...
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Monday, November 08, 2010 by
The 510(K) application is not restricted to "low risk" devices, in the sense of a critical function, but in the sense of how well the design of similar products is understood. Devices with "special controls", standardized requirements and test methods, irrespective of their clinical importance are generally 510(K) devices. New clinical data in such cases will rarely solve the problems identified in this article.
I believe that the number of 510(K) and special 510(K) problems relative to PMA device problems approximate the relative number of each. Tracking through the data at the FDA shows a huge number of manufacturing and supplier issues, compared to the number of design issues reported. It is unclear how, for any of these devices designed and build under special controls, additional clinical evidence will solve those problems.
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