In this webinar, Soumya Mahapatra, CEO of Essenvia, and Dhriti Roy, Vice President of Regulatory Affairs Transformation at Essenvia, will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources and operations to seamlessly adopt the eSTAR as the new submission standard. Dhriti will share watchouts, best practices, and tips and tricks to adapt to eSTAR.
In effort to improve the efficiency and consistency of the 510(k) preparation, submission, and review process, the US FDA has mandated the implementation of the electronic submission template (eSTAR) and eSubmission process to replace the standard eCOPY submission format effective October 1st, 2023 for 510(k) submissions, unless exempted per guidance and regulation.
This is the first milestone in a grander initiative to evolve FDA submissions to electronic format, including pre-submissions and supplements. In consequence, the elimination of eCOPY and launch of the eSTAR PDF submission template transforms the preparation and submission process for regulatory affairs organizations to favor review efficiency at the cost of submission efficiency for manufacturers - potentially creating a regulatory quicksand for medical device manufacturers without the appropriate planning, preparation, and adoption of eSTAR compliant tools and resources to smoothen the transition.
YOU'LL LEARN :
- What is eSTAR?
- How does eSTAR impact regulatory affairs moving forward?
- What are the main challenges that RA teams must overcome with eSTAR?
- How to prepare for eSTAR and immediately adapt to the new guidance and requirements
WHO SHOULD ATTEND:
- Regulatory and Quality Affairs (RA/QA) professionals from medical device, diagnostic, and pharmaceutical manufacturers that submit and commercialize 510(k) and De Novo 510(k) medical devices.