FDA seeks to reclassify hemodialysis access systems

07/9/2013 | MassDevice.com (Boston)

The FDA has issued draft guidance on its proposal to reclassify blood-access systems used during hemodialysis from Class III to the lower-risk Class II category. The agency cited sufficient efficacy and safety data to warrant the devices' reclassification. The guidance is up for comment through Aug. 27.

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MassDevice.com (Boston)

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