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The Food and Drug Administration (FDA) published several digital health policy resources this week, including new final guidance documents related to implementation of the 21st Century Cures Act (“Cures Act,” 2016), a corresponding informational tool to determine whether a software function is FDA-regulated, and a report of takeaway lessons following completion of the 2017 Software Precertification Pilot Program.

Reports

• — The FDA published a report of lessons learned following completion of the 2017 Software Pre-Cert Pilot Program, which involved a “TSA Pre-Check” style approach for FDA to certify device manufacturers who could then leverage expedited regulatory pathways to the market for certain software devices. The FDA indicated that a Pre-Cert Program could be a viable approach in the future, but that new legislation would be necessary to supplement the agency’s authorities.

Guidance Documents

• — This guidance addresses the FDA’s implementation of Cures Act Section 3060(a), which limited the agency’s regulatory authority over certain medical software functions, including CDS. The final guidance conveys the FDA’s understanding of the statutory criteria in Cures Act Sec. 3060 and how the agency delineates medical device software functions from non-device software functions using those criteria.
• — This guidance provides the FDA’s recommendations for 510(k) submissions of computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The relevant devices are regulated under 21 CFR 892.2050, “Medical image management and processing system” using product codes NWE, OEB, and OMJ.
• — This guidance for clinical performance assessments to support 510(k) submissions relates to the same subset of 21 CFR 892.2050 devices described in the above bullet, as well as devices using product code MYN under 21 CFR 892.2070 “Medical image analyzer.”
• — This guidance deals with a subset of 21 CFR 892.2050, “Medical image management and processing system” devices (product code PGY). Specifically, this guidance applies when a manufacturer includes a PGY display intended for use in diagnostic interpretation in a 510(k) submission along with other software or hardware. Real-time displays for image acquisition are excluded. Mobile displays under 892.2050 with the PGY product code are also excluded from this guidance, as they are addressed within the FDA’s mobile medical applications guidance.
• — This minor revision to existing guidance implements changes to conform with the FDA’s Cures Act implementation regulations and the CDS final guidance.
• — This minor revision updates the FDA’s enforcement discretion policy with respect to MDDS, medical image storage devices, and medical image communication devices. The radiology devices covered by this policy are under 21 CFR 892.2010 and 21 CFR 892.2020.

Other Resources

• — This informational tool helps stakeholders with their understanding of whether a particular software function is the focus of FDA regulatory oversight.

For any questions, please contact Michael Peters, 黑料网® Senior Government Affairs Director, Regulatory Policy.