September 29, 2020


Advocacy. Mediation. Success.

FDA issues digital health policy guidance for multiple function device products

On July 29, 2020, the US Food items and Drug Administration (Food and drug administration) issued advice for marketplace and Food and drug administration team with regards to several purpose unit items, updating draft advice launched in 2018. The term “multiple purpose unit product” usually means any merchandise with one or much more functions that are subject to Food and drug administration regulatory oversight as medical products and other functions that are not. Item functions are deemed medical products if they satisfy the definition of a “device” below the federal Food items Drug and…
By: Dentons