In 1980, the British rock band, Genesis, released “Misunderstanding.” Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory...more
The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more
On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...more
Recently, the Federal Communications Commission (FCC) proposed a $2.8 million fine against HobbyKing for allegedly marketing to amateur drone operators non-compliant models of devices used to relay video feed from the drones....more
The Federal Communications Commission is proposing to bring a $2.8 million penalty against HobbyKing for marketing drone-attachable audio/video (AV) transmitters that operate on unauthorized frequencies....more
Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more
On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more