February 9th, 2011
Posted by Patti Doherty, R.N.
On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
For context, here’s a current definition of the 510(k) program from the FDA website:
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.” Read the rest of this entry »
Tags: 510(k), cdrh, de novo process, FDA, healthcare providers, institute of medicine, jeffrey shuren, medical devices, pmn, premarket notification, task force on the utilization of science, working group
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