WHAT : Medtech World Bay Area Event WHERE : Signia Hotel by Hilton, San Jose 170 S Market St, San Jose, CA 95113 WHEN: June 27th, 2025 MedTech World Bay Area 2025 is just around the corner, and as the premiere regulatory affairs partner for startups in the medical device industry — and a […]
By Elle Winn, Mittal Consulting On August 22, 2024, the FDA released a new draft guidance discussing Predetermined Change Control Plans for Medical Devices. Predetermined change control plans (PCCPs) are FDA-authorized plans to implement changes to a medical device at a later point that are included in and approved in a marketing submission to the […]
This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA requests by third party review organizations. This draft guidance provides updated recommendations on the 510(k) Third […]