Decoding 21 CFR Part 814: A Guide to the FDA's Premarket Approval Pathway

This episode provides a detailed overview of the FDA's Premarket Approval (PMA) process, governed by 21 CFR Part 814. We explore the requirements for Class III medical devices, the necessary components of a PMA submission, including non-clinical and clinical data, the FDA's review timeline and procedures, and the post-approval responsibilities of manufacturers. • What is a Premarket Approval (PMA) and which devices require it? • How does the FDA define a Class III medical device? • What are the essential components of a PMA application under 21 CFR Part 814? • What kind of data is required in the non-clinical and clinical study sections? • What is the FDA's 180-day review timeline for a PMA? • What are the possible outcomes of an FDA review? • What is a PMA supplement and when is it required? • What are a manufacturer's post-approval responsibilities? • Can the FDA withdraw a PMA approval after it has been granted? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.