Medical Device Legal News with Sam Bernstein: Episode 18
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more
The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more