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The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.
If the manufacturer can demonstrate that the device won’t get to patients without some regulatory breaks, the FDA may grant approval based solely on a demonstration that the technology’s "probable benefits" outweigh its risks, Law360.com reported.
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