Devices

Multiple Function Device Guidance

FDA has published a guidance, Multiple Function Device Products: Policy and Considerations, to explain the agency’s regulatory approach and policy for all multiple function device products. Specifically, the document clarifies when and how FDA intends to assess the impact of “other functions” that are not the subject of a premarket review on the safety and effectiveness of a device function that is subject to FDA review.

“The purpose of this guidance is to identify the principles, premarket review practices, and policies for FDA’s regulatory assessment of such products, and to provide examples of the application of these policies,” the guidance says.

Contents of the guidance are Introduction, Background, Scope, Policy: Premarket Review of Multiple Function Device Products; Considerations for Multiple Function Device Products; Assessing the Impact of “Other Functions” on the Device Function Under Review; Content of a Premarket Submission for Device Function Under Review; Modifications to the “Other Function” of a Multiple Function Device Product; Application of Other Device and Postmarket Requirements; and Appendix.

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