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 comprehensive review of clinical and laboratory data.
Examples:
- Total hip replacement systems
- Artificial heart valves
- Implantable spinal cord stimulators
4/Emergency Use Authorization (EUA): This pathway is used to provide rapid access to medical devices during public health emergencies, such as pandemics.
Examples:
Sterilization and disinfection systems for reusable orthopedic instruments during a public health emergency
5/Humanitarian Device Exemption (HDE): This pathway is for medical devices intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year.
Examples:
Devices for the treatment of rare orthopedic conditions, such as achondroplasia (dwarfism).