US FDA publishes insight into 510(k) Substantial Equivalence determination process (MassDevice)
New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determinations.
US regulators have issued the new guidance to serve both as a resource for agency reviewers making SE determinations and as a tool for 510(k) applicants to more effectively demonstrate equivalence to predicate devices already on the US market.
The FDA bases its SE determinations on assessments of submitted devices' benefits and risks in comparison with their predicate devices, according to the new guidance.
First, FDA reviewers assess a 510(k) submission in terms of likely benefits that device would provide compared to its predicate device:
Type: How would the device benefit issues including clinical management, patient health and satisfaction, and probability of survival?
Magnitude: Would using the device achieve a pre-identified health outcome or threshold?
Probability: What percentage of this device's target patient population would benefit from using the product?
Duration...
