Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k) Requirement
By EsqSocial Corporation 08/02/21
In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed the same for 84 other devices ranging from gowns to ventilators....
By: Morgan Lewis