FDA regulators release a Q&A to clarify how medical device makers may seek Humanitarian Device Exemption for treating rare diseases.
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The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.
News Well, Humanitarian Device Exemption (HDE), Food & Drug Administration (FDA), Regulatory/Compliance
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