Tag Archives: premarket requirements

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”).  In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling.  Interoperability of devices … Continue Reading

FDA to Reorganize its Device Compliance Office with Increased Focus on Oversight of Advertising, Promotion, and Premarket Requirements

FDA recently announced that it is planning to reorganize the Office of Compliance within the Center for Devices and Radiological Health.  The changes will become effective in mid-November. The Office of Compliance plans to move “from a product-based structure  . . . to a function-based structure.”  At the moment, the Division of Enforcement A and Division … Continue Reading