New Draft FDA Guidance for Devices with More than One Function

oday, the FDA issued a draft guidance related to Digital Health and the 21st Century Cures Act aimed at clarifying the FDA’s policy for products with multiple functions that include at least one device function. Starting tomorrow, you can submit your comments to the docket by June 26, 2018.

The FDA does not regulate certain software functions that do not meet the statutory device definition if they are contained in a multiple function product. However, the FDA may assess the impact of the software function on the safety and effectiveness of the device under FDA’s premarket review. 

The draft guidance, “Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff” proposes that when assessing a multiple function device product, manufacturers and the FDA should determine if any other function may impact the safety or effectiveness of the device function under FDA’s premarket review. If so, the impact should be evaluated to determine whether the other function has a positive or negative impact on the device function in their premarket submission.  The guidance details what should be included in the premarket submission of a multiple function product, if the other function could adversely impact the device function under FDA’s premarket review. 

The FDA recommends that when possible, the device function under FDA’s premarket review should be separated from other functions of the device, and that the higher the degree of separation, the easier it is for the agency to independently review it for safety and effectiveness. 

Issuing guidance to provide clarity for manufacturers, FDA staff, and other stakeholders on the medical software provisions of the 21st Century Cures Act is part of the FDA's long-term Digital Health Innovation Action Plan.

If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email digitalhealth@fda.hhs.gov.

Upcoming User Session: On Thursday, May 10, 2018, the FDA will host an interactive session to discuss progress the agency has made on the Software Precertification Pilot Program. Webcast is available and no registration is required. 

Food and Drug Administration