Temporary COVID-19 Policies Becoming Permanent
By EsqSocial Corporation 27/01/21
On Jan. 15, 2021, the U.S. Department of Health & Human Services (HHS) issued a notice, “Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements.” With this notice, HHS provided an overview of data collected on medical device adverse events. HHS immediately exempted certain medical devices from the requirement to obtain premarket clearance. This shift in policy shows that HHS may...
By: BakerHostetler