FDA Forum for Interoperability Feedback

Join the FDA and NITRD on July 17 for a Listening Session on Interoperability of Medical Devices

On July 17, 2019, the U.S. Food and Drug Administration (FDA) and The Networking and Information Technology Research and Development Program (NITRD) will host a listening session on the interoperability of medical devices, data and platforms. During the listening session, federal stakeholders will listen to the session participants explore solutions that promote a shared future vision of next generation, interoperable, and intelligent health systems. The feedback received from the listening session will provide potential research directions for advancing medical device interoperability.

Meeting Details

  • Date: July 17, 2019
  • Location: The FDA’s White Oak Campus, Great Room – 10903 New Hampshire Avenue, Silver Spring, MD 20993
  • Time: 8:00 a.m. – 5:00 p.m.
  • Registration Required, Webcast Available

Listening Session Link

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on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1).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.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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