FDA para eximir los cassettes de la radiografía a partir el 510 del proceso (k)

por Brendon Nafziger, DOTmed News Associate Editor | July 11, 2011
The Food and Drug Administration said it could exempt some radiology accessories such as X-ray film cassettes, processors and digitizers from its 510(k) clearance process. The down-regulation comes as the FDA seeks to reclassify dozens of devices deemed safe enough to not require premarket notification.

Under the new rules, first announced last week but published Monday, the agency said it would use its discretion as to whether submissions for nearly 30 device categories, including blood and urine tests, alcohol breath tests and blood-clotting protein tests, would require going through the 510(k) process.

This clearance process, generally used for moderate-risk, Class II devices, requires companies to submit safety information and to show the device resembles similar products already on the market.
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"The safety and effectiveness of these devices have been well demonstrated over the years," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.

The 19 radiology devices the agency proposes exempting include automatic and manual radiographic collimators, film cassettes, digitizers, processors, film dryers and pneumocephalographic chairs.

The FDA's accepting comments on the rules for the next 90 days. Meanwhile, the agency said it wouldn't enforce the premarket notification requirements for these devices provided they don't fall under the exemption limitations in existing device regulations.

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