##  [Foundation Masterclass: 510(k) Clearance Pathway](/webinars/foundation-masterclass-510k-clearance-pathway) 

<a>Medical Devices</a>



<a>Past Webinar</a>



## **Foundation Masterclass: 510(k) Clearance Pathway**

**The webinar was successfully concluded on**

  **September 07, 2022.**

[Download Webinar](javascript:void(0))





We are pleased to see your interest in Freyr’s Webinar Series (FWS). The webinar on **“Foundation Masterclass: 510(k) Clearance Pathway”** was successfully concluded on **September 07**, 2022. Here is an archived version of the session for your perusal.

#### What Was It All About?

In this webinar, our in-house Regulatory expert, Shilpa Gampa, Head-Medical Device Regulatory Affairs- US, Canada, and EU, have discussed the below aspects:

- How to identify and narrow down predicate devices for 510(k) clearance
- Effective strategies for establishing a substantial equivalence with the predicate device
- Key considerations for digital health product submissions
- When to opt for Pre-submission and Q-submission meetings with US FDA
- Major deficiencies during the substantiative review and how to avoid them
- Do and don’ts for the eSTAR program
- Case studies
- Frequently Asked Questions (FAQs) on 510(k) registrations