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  5. Webinar - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance - November 1, 2018 - 11/01/2018 - 11/01/2018
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Webcast

Event Title
Webinar - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance - November 1, 2018
November 01, 2018


Date:
November 01, 2018
Time:
11:00 AM - 12:30 PM EDT
Organized By:

Webinar Materials

As technology continues to evolve, medical devices reviewed under the premarket notification (510(k)) process often have technological characteristics that differ from those of a legally marketed predicate device. On September 24, 2018, the FDA released a final guidance about the factors the FDA considers when evaluating benefits and risks of a new device compared to a predicate device during a 510(k) review when the FDA has determined that the intended use of the device is the same, but there are different technological characteristics. The recommendations in the final guidance do not change the 510(k)premarket review standard or require 510(k) submitters to provide additional performance data beyond what would normally be requested during the review process.