Reed Smith Client Alerts

On September 6, 2017, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices.” This Guidance is intended to address the tension between interoperability and security of medical devices by identifying specific issues interoperable medical device manufacturers should consider in the development and design of their products; it also provides specific recommendations regarding the contents of pre-market submissions and device labeling. The Guidance is part of a larger effort, at both the federal and state level, to ensure safe medical devices.

Authors: Mildred Segura Maryanne C. Woo Christopher M. Butler

Type: Client Alerts

On September 6, 2017, almost two years after first issuing its draft guidance, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Guidance”)1. This Guidance is intended to address the tension between interoperability and security of medical devices by identifying specific considerations when developing and designing interoperable medical devices; it also provides specific recommendations regarding the contents of pre-market submissions and device labeling.