dilluns, 24 de març del 2014

FDA updates medtech fast-track review for rare treatments | MassDevice.com On Call




FDA regulators release a Q&A to clarify how medical device makers may seek Humanitarian Device Exemption for treating rare diseases.






MassDevice.com On Call


MASSDEVICE ON CALL — U.S. healthcare regulators released new documents in efforts to clarify the FDA's Humanitarian Device Exemption pathway, a less-stringent review process for medical devices that treat rare diseases.


The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.




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