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

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

March 24, 2014 By Arezu Sarvestani

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The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.

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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Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Humanitarian Device Exemption (HDE)

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