Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more
Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions.
On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more
FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices....more
Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered.
On December 7, the Internal Revenue Service (IRS)...more