Partner Dennis Gucciardo spoke with BioWorld MedTech about the US Food and Drug Administration’s (FDA’s) draft guidance for premarket submissions of device software functions—a document that puts much greater emphasis on risk considerations. While most of the new guidance will likely strike long-time industry participants as standard, Dennis said members of the digital health space who are novices to FDA regulation will find the draft helpful. He also shared that the draft guidance is long overdue, given the explosion of software as a medical device over the past decade and a half.
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