Radio and PodcastLive Radio & Podcasts
Business
FDA 101: Understanding the OTHER Regulatory Giant
Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer , we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substant...
About This Episode
FDA 101: Understanding the OTHER Regulatory Giant is an episode from RA/QA Today by RAQA Today. Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer , we break down the U.S. Food and Drug Adm...
Podcast
This episode belongs to RA/QA Today.
Listen Online
Use the player on this page to stream the episode online.
Episode Details
Published Sep 8, 2025, 00:23:44 long, audio available.
Related Episodes
Continue listening to more episodes from RA/QA Today.
How to be the Regulatory Person Everyone Actually Likes Device & Conquer S2:E6
Dec 2, 2025 - 00:17:02
How to Build a Quality System That Doesn't Suck Device & Conquer S2:E5
Nov 18, 2025 - 00:15:53
Due Diligence for MedTech Investors: What You Really Need to Know Before Writing That Check
Nov 17, 2025 - 00:58:42
Why Picking a Predicate Can Make or Break Your 510(k) Device & Conquer S2:E4
Nov 11, 2025 - 00:19:26
How to Build a 510(k) Without Losing Your Mind Device & Conquer S2:E3
Nov 3, 2025 - 00:20:02
How to Submit a Pre-Sub (like a Pro) Device & Conquer S2:E2
Oct 28, 2025 - 00:16:50
Questions About This Episode
What is FDA 101: Understanding the OTHER Regulatory Giant about?
Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer , we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de novos, and PMAs. Learn how the FDA oversees everything from tongue depressors to pacemakers and why regulatory strategy can make or break your product’s success. Watch the video version on YouTube:
Where can I listen to FDA 101: Understanding the OTHER Regulatory Giant?
You can listen to FDA 101: Understanding the OTHER Regulatory Giant online on Radio and Podcast. Open the player on this page to stream the available audio.
Which podcast is FDA 101: Understanding the OTHER Regulatory Giant from?
FDA 101: Understanding the OTHER Regulatory Giant is an episode from RA/QA Today by RAQA Today.
How long is this episode?
This episode is 00:23:44 long.
When was this episode published?
This episode was published on Sep 8, 2025.
Can I save FDA 101: Understanding the OTHER Regulatory Giant for later?
Yes. Use the heart button on the episode page to add it to your favorite episodes list.
Are there related episodes from RA/QA Today?
Yes. This page shows related episodes from RA/QA Today when more episodes are available from the podcast feed.
Quick Answers About This Episode
Where can I listen to FDA 101: Understanding the OTHER Regulatory Giant?
You can listen to FDA 101: Understanding the OTHER Regulatory Giant on this page when the episode audio is available from the podcast feed.
Which podcast is this episode from?
FDA 101: Understanding the OTHER Regulatory Giant is from RA/QA Today by RAQA Today.
What are the episode details?
Published Sep 8, 2025 and 00:23:44 long