Devices & Diagnostics Letter

A working group comprised of FDA officials and various stakeholders is hoping to draft a “roadmap” to facilitate implementation of the agency’s unique device identifier (UDI) system, one FDAer told D&DL.

A new Medicare Physician Fee Schedule requirement that doctors document an in-person encounter with beneficiaries before being reimbursed for durable medical equipment (DME) they provide has some in the industry worried that suppliers may not be paid.

Los Angeles weight-loss surgery clinic Lap-Band VIP has received an FDA warning letter for misleading marketing claims.

A federal judge has ordered the FDA to release additional pages of logs and documents concerning its surveillance of six current and former employees who reported device safety concerns to Congress and the U.S. Office of Special Counsel (OSC).

Edwards Lifesciences experienced healthy growth in second-quarter earnings, thanks to rapid adoption of its SAPIEN transcatheter heart valve, the company said during a Tuesday earnings call.

Color-coding or labeling tubes to reduce risks associated with enteral tube misconnections will no longer be considered enough of a precaution under a new FDA draft guidance.

Countries in the Association of Southeast Asian Nations (ASEAN) would have to establish postmarketing surveillance alert systems to report and evaluate device-related adverse events and make the information available to other member states under a draft medical device directive released for comment this summer.

A medical device alleged to melt cellulite should be removed from the market immediately because it poses a significant safety risk and was never cleared by the FDA, patient advocacy group Public Citizen says in a July 18 letter to the FDA.