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The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.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.
Scottish petition calls for suspension of pelvic mesh devices
A Scottish patient advocacy group is circulating a petition to ban the use of
polypropylene mesh medical implants, which are the subject of controversy and legal action around the world.
European mobile health laws mirror U.S. regulation
Mobile healthcare regulations unveiled in the U.K. are largely similar to those recently unveiled by the FDA’s medical device arm.
Michigan U. researcher in hot water for sending MRI coil to Iran
University of Michigan medical researchers Mohamad Nazemzadeh was arrested on allegations that he conspired to ship an MRI coil to Iran in a move that brought harsh criticisms for the export law that he allegedly violated.