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See today's BioWorld MedTechSee today's BioWorld
Home » Stakeholders prod FDA to include drugs in scope of device software functions guidance
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Stakeholders prod FDA to include drugs in scope of device software functions guidance

Feb. 10, 2022
By Mark McCarty
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.
BioWorld BioWorld MedTech Regulatory Combination drug-device Software U.S. CDRH FDA

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