The FDA has released draft guidances for the first four types of devices it will evaluate under its expedited Safety and Performance-Based Pathway to 510(k) clearance. They are:
- Conventional foley catheters.
- Cutaneous electrodes for reporting purposes.
- Orthopedic non-spinal metallic bone screws and washers.
- Spinal plating systems.
Developers of these types of devices will no longer need to provide the FDA with a side-by-side performance assessment with a predicate device. They will only need to demonstrate that their device is equivalent or superior through certain safety and performance criteria set by the agency.