FDA Insights for HealthTech Startups; Podcast Interview with Attorney Katherine Giannamore

Are you a health tech startup navigating the complex world of medical device regulation? Join us on the Delta podcast as we delve deep into the FDA's regulatory landscape with seasoned attorney Katherine Giannamore.In this enlightening interview, we explore:

🔍 FDA Regulations Demystified: Discover the ins and outs of how the FDA regulates medical devices. Katherine simplifies the complexities, helping startups understand the regulatory pathways

.🛤️ Navigating the Pathways: Learn about the various pathways health tech innovators can take to bring their medical devices to market.

💡 Common Pitfalls & Myths: Uncover the misconceptions that often trip up startups. Gain insights to avoid these pitfalls and streamline your regulatory journey.📈 For Health Tech Startups:

This discussion is tailor-made for health tech entrepreneurs aiming to bring groundbreaking innovations to the market. It's your roadmap to success

Whether you're developing wearable health monitors, cutting-edge diagnostic tools, or revolutionary medical devices, this podcast interview is a must-watch.

Timestamps:

04:27 What is the definition of a medical device?

16:23 What are the classes of medical devices?

27:45 What are the FDA regulatory pathways for medical devices?

41:52 How does the FDA assess the safety and effectiveness of a medical device?44:52 How to expedite FDA application processing?

46:32 Software as a Medical Device

55:42 Pitfalls startups should avoid

1:01:26 Myths About FDA Approval

Attorney Katherine Giannamore's contact information:

Email: kgiannamore@giannamore-law.com

LinkedIn Profile: https://www.linkedin.com/in/katherine-giannamore-258a9b64/

Website: https://sglawfl.com/katherine-giannamore-esq/

Roupen Odabashian

LinkedIn: https://www.linkedin.com/in/roupen-odabashian-183aaa142/

Twitter: https://twitter.com/RoupenMD