FDA's Medical Device Software Regulation Strategy will focus on addressing these concerns and educating participants on FDA's recent medical device .. Read more software regulation strategies. The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.
Casper (Cap) UldriksFormer Associate Center Director of FDA's CDRH
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