Devices

Multiple Function Device Guidance

FDA has published a draft guidance, Multiple Function Device Products: Policy and Considerations, to explain the agency’s regulatory approach and policy for all multiple function device products. The document says medical products may contain several functions, not all of which are subject to FDA regulatory oversight as medical devices. For purposes of the guidance, it says, for any given product the term “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use. Products with at least one device function are referred to as “multiple function device products.”

The draft’s purpose is to identify the principles, premarket review practices, and policies for FDA regulatory assessment of such products and to provide examples of the applications of these policies.

Included in the guidance are an Introduction, Background, Scope, Policy, Considerations for Multiple Function Device Products, Assess the Impact of Other Functions on the Device Function Under Review, Content of a Premarket Submission for Device Function Under Review, Application of Other Device Requirements to Device Function, and two appendices.

In addition, FDA has released a working model for the Digital Health Software Precertification Program that provides the agency vision for the pilot while asking for specific input from stakeholders to allow continued improvement for the innovative program.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome