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Israel-based Theranica Bio-Electronics’ Nerivio remote electrical neuromodulation (REN) device can now be used as a preventive treatment for migraine, having received an expansion of its de novo marketing clearance the FDA granted in 2019 for acute migraine treatment.
The FDA has enrolled four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, which is designed to give faster, more widespread access to medical devices of public health importance and strengthen the agency’s Breakthrough Devices program.
The FDA’s latest updates to its Electronic Medical Device Reporting (eMDR) system will go live on March 17, making five changes to the online system devicemakers and importers must use to submit MDRs.
The association is urging lawmakers to enact the bipartisan Verifying Accurate Leading-edge IVCT Development Act (VALID) which would require the FDA to regulate in vitro clinical tests.
The FDA’s process for bringing devices to market starts with a device’s risk classification and moves next to the level of controls placed on the device — not only for approval purposes but also for manufacturing, labeling, packaging and other activities that are monitored throughout a product’s lifecycle for enforcement purposes.
Texas-based Dalton Medical, a manufacturer of powered wheelchairs, adjustable hospital beds and other durable medical equipment, received a Form 483 for failure to establish design control and complaint handling procedures, among other lapses.