FDA final guidance - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
https://www.fda.gov/downloads/Medic...d29a1d&elqaid=5190&elqat=1&elqCampaignId=4154
https://www.fda.gov/downloads/Medic...d29a1d&elqaid=5190&elqat=1&elqCampaignId=4154