Tom Cowan

Tom Cowan

Knobbe Martens

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FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

8/11/2016  /  510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Modification , Software
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