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 market.
Examples:
Knee replacement implants
Intervertebral spinal fusion devices
Lumbar artificial disc replacements
2/De Novo classification: This pathway is for new medical devices that do not have a predicate device to reference for substantial equivalence. De Novo is an expedited review process for low- to moderate-risk medical devices.
Examples:
3D printed spinal implants
Novel joint reconstruction devices
3/Premarket Approval (PMA): This is the most stringent regulatory pathway for medical devices. PMA is required for high-risk medical devices, such as implantable devices, and involves a c...
