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Complimentary Webinar Recording
|Recorded on September 21, 2023|

Crossing the eSTAR Chasm:
 Transitioning to FDA's Mandatory 510(k) eSTAR Submission Process by October 2023

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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. 

SPEAKERS

Dhriti Roy

Dhriti Roy, PhD
VP, Regulatory Affairs Transformation
Essenvia

Dr. Dhriti Roy is the VP of Regulatory Affairs Transformation at Essenvia, with 20+ years of experience in MedTech, leading quality, regulatory, and clinical strategies for large and early-stage organizations. She specializes in 510(k)s, IDEs, PMAs, MDRs, IVDRs, FDA QSR, compliance with SIMDs and SAMDs, and is involved in global regulatory efforts for M&A deals. Dhriti is also an eminent scientist, RAC, CQM, Master Black belt, and a faculty at Oxford University's MedTech innovation platform.

SoumyaMahapatra

Soumya Mahapatra
CEO
Essenvia


Soumya Mahapatra is a seasoned technologist, product leader in Healthcare with over 18 years leading strategic digital transformation initiatives at Fortune 500 companies. He experienced first hand how complex, manual and painful regulatory processes are and founded Essenvia to solve this problem to accelerate medical device innovation. His goal is to elevate Medical device regulatory affairs by reducing inefficiencies to transform medical device regulatory processes. Essenvia has worked with over 80 companies and managed 300+ regulatory submissions across 510(k)s, Pre-Subs, TDs, IDEs to help achieve faster time to clearance.

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