USA – US FDA ramping up permanent 510(k) exemptions for dozens of low-risk medical devices

The US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification requirements, and has proposed similar exemptions for several other device types to expand access to these  products during the COVID-19 public health emergency. The devices identified

According to a recent FDA notice, the seven Class I device types permanently exempt from 510(k) requirements include surgical and examination gloves; these exemptions took effect January 15, 2021…