Navigating FDA Premarket Notifications (510k) and Preclinical Testing
A Practical Guide for Indian MedTech Start-ups
What to expect
Gain insights into the specific requirements and best practices for US FDA medical device submissions.
- FDA regulatory pathways and resources for med-tech startups, including how to determine substantial equivalence, select a predicate for the 510(k) Premarket Notification process, navigate timelines, and request reviewer feedback.
- Preclinical testing strategies, with a focus on performance studies, biocompatibility assessments under ISO 10993, and verification and validation strategies.
- Practical examples on structuring test protocols, justifying sample sizes, documenting verification and validation results, and tips for making a submission “easy to review.”
Speaker: Tanmay Jain
A polymer scientist with 6+ years at the U.S. FDA (CDRH) as a lead reviewer, specializing in polymer-based medical devices. His expertise spans device performance, biocompatibility, and regulatory standards, covering implants, surgical tools, and 3D-printed technologies. He co-founded ProfProtects, an award-winning startup developing opioid-detecting polymer mats, now being licensed globally. He currently advises med-tech startups on regulatory strategy, materials evaluation, preclinical testing, and product development..
Selected 4 startups get a chance to have one-on-one mentoring with the expert. [Details of the mentoring slots will be shared separately with the selected startups]
For Queries
Aishwarya Varpe | aishwarya.varpe@venturecenter.co.in | 9156465137
