[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”
A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far […]
[FEATURED] FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software […]
Nuances of Using the Safety and Performance Pathway for Submitting a 510(k) for Certain Device Types
Author: Suzanne Broussard, PhD | November 2, 2020 The FDA is moving forward with its commitment to strengthen and modernize the 510(k) program. The Safety and Performance Based Pathway is designed to provide a direct […]
