FDA Final Guidance: Interoperable Devices

The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a section on information on interoperability to be included in premarket submissions.

Section V identifies six key considerations under 21 CFR 820. Key design considerations identified include:

  • purpose of the electronic interface
  • anticipated users
  • risk management
  • V&V
  • labeling
  • use of consensus standards

Section VI of the guidance defines information to be included in premarket submissions, including a description of the API (Application Programming Interface) if the software can be used by other software, medical devices, or systems.

Take a look at the guidance here:  Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for 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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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