When developing a new orthopedic device or product, you need to consider the most appropriate FDA pathway to take. Most of us have the most experience with 510(k)s but there are 4 other pathways.
Let's review.
The US Food and Drug Administration (FDA) has several regulatory pathways for medical devices to be cleared for marketing in the United States. They include:
1/510(k) clearance: This is the most common pathway for medical devices to be cleared by the FDA. A device is eligible for 510(k) clearance if it is substantially equivalent to a legally marketed device that is already on the marke...
The Orthopedics Industry 