The FDA Issues Final Guidance – Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics

Today, the U.S. Food and Drug Administration (FDA) released the final guidance document, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics.” The recommendations in this guidance are intended to promote consistency, predictability, and transparency in the device submission review process when determining substantial equivalence for devices with different technological characteristics.

A 510(k) submission must demonstrate to the FDA that a new device is substantially equivalent to a predicate device. However, as technology continues to evolve, medical devices reviewed under the premarket notification (510(k)) process may have technological characteristics that differ from those of the legally marketed predicate device. Technological characteristics include materials, design, energy source, or other features of the device. This guidance identifies circumstances when a benefit-risk assessment comparing a new device to a predicate device may be relevant. For example, this guidance may provide clarity in situations when there is:
an increase in risk and increase or equivalent benefit, or
a decrease in benefit and a decrease or equivalent risk when comparing a new device to a predicate device.
This guidance does not add new requirements for submitters, it does not change the 510(k)-premarket review standard, nor does it create extra or new burdens on 510(k) submissions. Instead, the benefit-risk factors discussed in this guidance may assist submitters of 510(k)s demonstrate substantial equivalence when the new device has differences in technologies from the predicate device.

On November 1, the FDA will host a webinar for manufacturers and others interested in learning more about this guidance.

For additional information on the 510(k) premarket review process, please visit the Premarket Notification 510(k) webpage.

If you have questions about substantial equivalence in premarket notifications (510(k)) with different technological characteristics, please contact the FDA Division of Industry and Consumer Education (DICE) at the Center for Devices and Radiological Health. Contact DICE at (800) 638-2041 or 301-796-7100 between 9:00 a.m. – 12:30 p.m. and 1:00 p.m. – 4:30 p.m. Eastern Time or by email at DICE@fda.hhs.gov. Or you can write to the FDA’s 510(k) Program staff at 510k_Program@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health

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