Complete FDA PMA submission guide
Ace your FDA PMA submission and get your Class III device to market with our roadmap guide.
Instant access. No email required.
Download our complete FDA PMA submission guide to:
- Understand the end-to-end process for completing the FDA's premarket approval (PMA) process
- Access top tips, common mistakes to avoid, handy insights from real quality professionals and more
- Drive a confident, successful right-first-time submission with all required ingredients
What you'll get:
PMA roadmap
Master the entire PMA process, from classifying your device and choosing a submission type to gathering your submission ingredients
Submission demystified
70% of PMAs are rejected on first review. Learn where other medical device businesses typically go wrong and dodge common myths and mistakes
Class III market access
Master your PMA obligations and drive a smooth, stress-free and right-first-time approach that gets your Class III medical device to the US market for good