Omnibus is here. As of March 29, 2023, the FDA expects medical device manufacturers (MDMs) to have all the information ready under section 524B. Those who do not risk the FDA sending an RTA (refuse-to-accept) decision, significantly delaying new product launches. That said, until October 2023, the FDA will not refuse to accept premarket submissions for review while MDMs get up to speed with necessary requirements.
Cybellum’s Omnibus Preparedness Accelerator allows MDMs to be better prepared for the October enforcement by combining a powerful product security platform with expert services.
What's included in Cybellum's Omnibus Preparedness Accelerator
A compliance acceleration service by product security experts
A dedicated Product Security Platform used by leading medical device manufacturers, enabling the automation of main processes
Covers SBOM Management, Vulnerability Management, Incident Response, 510(k) Preparation, and more