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Life Sciences Co-Chair Quoted in FDA Week and Inside Health Policy on Draft Guidance Regarding Medical Device Software Modifications to Improve Cybersecurity

Practices: Life Sciences

Life sciences partner Greg Levine (Washington, D.C.) was quoted in FDA Week and Inside Health Policy on Aug. 12 regarding U.S. Food and Drug Administration (FDA) draft guidance stating that medical device manufacturers can make software modifications to improve cybersecurity or restore a device to recently cleared specifications without having to submit new 510(k) documentation.

Mr. Levine explains that while the new FDA guidelines are clearer than previously existing medical device software modification guidance, it is still vague and open to interpretation. 

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