How can medical device developers gain FDA approval for their devices and permission to sell their product into the US market? How does FDA device classification work and what impact can it have on the timings and complexity of the compliance process?
What’s the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products. PMA submissions typically take longer to secure and require more evidence such as clinical trial data, to prove that a device is safe and effective for its intended users.