Dec 9, 2019

The US Food and Drug Administration has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019.

The announced framework pertains to the agency’s planned expansion of its previous Abbreviated 510(k) Program; FDA intends to offer the pathway as a less onerous US market authorization route for the Safety and Performance Based Pathway will be fully implemented following identification of suitable device types and performance criteria as well as publication of final guidance.

For the time being, FDA has issued new details regarding appropriate device types for the new program, plus recommendations on what to include in Safety and Performance Based 510(k) premarket notification submissions to the regulator. The new program was first announced in September 2019.

Device types appropriate for the FDA Safety and Performance Based Pathway

The new framework document identifies five Class II device types for which the agency intends to establish performance criteria and testing methodology guidances ahead of launching the Safety and Performance Based Pathway:

  • Spinal plating systems
  • Cutaneous electrodes for recording purposes
  • Conventional foley catheters
  • Orthopedic non-spinal metallic bone screws and washers
  • Magnetic resonance coils

Devices qualifying for the Safety and Performance Based Pathway for 510(k) clearance should have the same indications for use as their identified predicate devices, and their technical characteristics should not lead to different safety and effectiveness issues or concerns as those of their predicates. In addition, qualifying devices should meet all performance criteria identified by FDA.

Safety and Performance Based 510(k) application content

FDA also provides high-level recommendations as to what to include in a 510(k) premarket submission under the Safety and Performance Based Pathway program, but notes that specific types of application data will depend on performance criteria and testing method sources.

“Importantly, 510(k) submitters still need to identify a predicate for certain aspects of substantial equivalence,” FDA states. “However, instead of conducting direct comparison testing to demonstrate that a device is as safe and effective as a predicate device, manufacturers will have the option to use this pathway to demonstrate substantial equivalence, when appropriate.”

Learn more about US FDA 510(k) requirements for medical device manufacturers:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA medical device classification support
  • Regulatory process chart: US FDA registration for medical devices and IVDs
  • Webinar: Obtaining 510(k) clearance from US FDA

Author

  • Stewart Eisenhart

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