In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
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...more
2/8/2021
/ 510(k) RTA ,
Biden Administration ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Pre-Market Notification ,
Premarket Approval Applications ,
Regulatory Reform ,
Regulatory Requirements ,
Safety and Performance Pathway
Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
1/8/2021
/ Biden Administration ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Digital Health ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry