In US, there are three types of Premarket Notification 510(k)s that may be submitted to FDA for medical devices: Traditional; Special; and Abbreviated. In 2019, the FDA decided to expand the concept of the Abbreviated 510(k) pathway for certain well understood device types, using the Safety and Performance Based pathway.
When to Use the Safety and Performance Based Pathway?
The Safety and Performance Based pathway can be used when:
1. The new device has the same indication for use and that their technological characteristics do not raise different question of safety and effectiveness as their predicate device,
2. The performance criteria align with the performance of one or more legally marketed devices,
3. The new device meets all FDA performance criteria.
What Devices Qualify for the Safety and Performance Pathway ?
The FDA has identified the following five Class II devices for which they have issued drafts for the devices’ performance criteria and testing methodologies:
• Spinal plating systems
• Cutaneous electrodes for recording purposes
• Conventional Foley catheters
• Orthopedic non-spinal metallic bone screws and washers
• Magnetic resonance coils
What to submit in 510(K) based on Safety and Performance Pathway?
to demonstrate that the new medical device is substantially equivalence in the Safety and Performance program the FDA expects the submitter to demonstrate that the new device meets the FDA-identified performance criteria by submitting:
• Declaration of Conformity– to an FDA-recognized consensus standard,
• Testing protocols,
• Results summary,
• Complete Test report.
However, application content depends on the device. Not all of the application content listed is necessary to show substantial equivalence. For more details, please refer to the Safety and Performance Based Pathway guidance.
Food and Drug Administration.(2019, September). Safety and Performance Based
Pathway- Guidance for industry and Food and Drug Administration.
Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance- documents/safety-and-performance-based-pathway
Whitepaper: 510 (k) Premarket Notification
Whitepaper: How the FDA Defines Substantial equivalence in Predicate Device