The draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics has recently been posted.
A submitter of a premarket notification submission (often referred to as a 510(k)) must demonstrate to the Food and Drug Administration (FDA) in its 510(k) submission that the new device is “substantially equivalent” (SE) to a legally marketed (predicate) device. At certain points in the substantial equivalence analysis, the probable benefits and risks of a new device as compared to a predicate device may be relevant. The benefit-risk factors discussed in this guidance may assist FDA reviewers in making substantial equivalence determinations and may help accommodate evolving technology during the 510(k) premarket process. This guidance may also help submitters of 510(k) premarket notifications demonstrate substantial equivalence in their premarket submissions. FDA has developed this guidance in order to improve the predictability, consistency, and transparency of the 510(k) premarket review process. This guidance does not change the 510(k) premarket review standard or create extra burden on a submitter of a 510(k) to provide additional performance data from what has traditionally been submitted during the review process for 510(k) submissions.
For more information, please see: http://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm404770. htm