FDA Digital Health Precert Meeting Summary

Sandy Hedberg and Brian Pate of SoftwareCPR highlight a few key points from the meeting. The FDA’s Digital Health Precertification webpage is at the link provided and the slides from their presentation can be downloaded. Basically, the premise is that the FDA will pre-certify a company. Pre-certification will result in a certification level. Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review. The FDA will also require real world data collection.

The FDA did not provide much detail as they intend to develop the details as they go through the pilot. The FDA hopes to enroll around 9 companies in the pilot who are established in software development. It is interesting that the FDA is including a range of device risk and not just focusing on low risk devices. Another interesting aspect is the idea of an SaMD RDK (Regulatory Development Kit) as indicated in one of the FDA slides. This would be an online interactive aide to those developing SaMD in ensuring regulatory compliance and safety. If successful, this new approach may help SaMD manufacturers support more rapid software release and updates, as is common with commercial software products. Precertification (Pre-Cert) Pilot Program: Milestones

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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