Safety and Performance Based 510(k)

Safety and Performance Based 510(k) 2

The Safety and Performance Based Pathway is generally preferred for well-understood medical devices choosing Abbreviated 510(k) as the clearance pathway.

The FDA expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final guidance has been published.

The main advantage is that, once this pathway is operational is that medical device manufacturers will have the option to meet FDA-identified performance criteria to demonstrate that its device is as safe and effective as a predicate device.

Safety and Performance Based 510(k) 3

What device types are appropriate for the Safety and Performance Pathway? Is there any difference in the content of a Safety and Performance-Based 510(k) and the traditional/ abbreviated 510(k)?

The safety and performance based 510(k) is used to demonstrate that the new device meets the safety and effectiveness of a legally marketed device by using FDA identified performance criteria as bench mark

The Safety and Performance based Pathway is suitable when:

  • The new device has the same indications for use and technological characteristics as of predicate and does not have any concerns over safety and effectiveness of identified predicate device
    The FDA-identified performance criteria is met by the new device.
  • If any of the factors mentioned above are not met, the submitter have the option to submit a Traditional, Special or Abbreviated 510(k).
  • The Safety and Performance 510(k) path is also like any other Abbreviated 510(k) s mainly relies on the guidance documents, recognized standards and special controls to analyze conformance assessments and demonstrate substantial equivalence.
  • The Abbreviated 510(k) submission method differs significantly from the Traditional 510(k) and Special 510(k) submissions since it depends on established regulatory guidance, standards and specific controls. Special 510(k)s focus mainly on device modifications and their compliance with design controls, not as the whole device.
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