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Theravance Biopharma and Viatris have alleged that multiple competitors infringed on patent protections for Yupelri (revefenacin) — a combination drug-device product used to treat chronic obstructive pulmonary disease (COPD) — by developing generic versions.
To help prevent the approval of AI medical devices that “mirror or exacerbate” existing health disparities, the FDA should develop a “distinct regulatory process” for artificial intelligence (AI)-driven software as a medical device (SaMD), say several academic researchers.
Having solid design and process verification baked into the product lifecycle is a challenge for devicemakers as it calls for effective collaboration between separate units, according to one medical device quality and regulatory expert.
The FDA issued Rochester, N.Y.-based Fieldtex Products a Form 483 with eight observations for not properly evaluating its suppliers, inadequate handling of nonconforming product and other deficiencies.
In a 537-3 vote, the European Parliament passed an amendment to extend the transition period for manufacturers to comply with the Medical Devices Regulation (MDR) to prevent shortages of medical devices.
The FDA hopes to see the new Congress reconsider the VALID Act — which failed to become law last year — for its ability to create transparency for in vitro clinical tests and improve emergency preparedness, said Elizabeth Hellebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiologic Health.