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

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.