FDAnews Device Daily Bulletin

U.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states.

The U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations.

The Chinese Department of Health has issued a field safety notice for Cordis’ S.M.A.R.T. Control Nitinol stent system due to a sterility breach in all pouches of the stent system.

French Health Minister Xavier Bertrand on Wednesday announced tighter controls over the market for risky medical devices, in the wake of the faulty breast implant scandal.

Ireland is being positioned as a global leader of the medical technology sector by 2015, with the industry set to be a “key driver” in the country’s ongoing export-led economic growth.

The Aesthetic Surgery Journal published an article by Emory University researchers on an FDA Class 1 device used in the delivery of silicone gel implants.

Idaho Technology has filed for FDA 510(k) clearance of five additional respiratory pathogens for its FilmArray respiratory panel.

Bovie Medical announced that the it received 510(k) clearance from the FDA to market its J-Plasma hand piece with retractable cutting feature for soft tissue coagulation during surgery.

Discovery Laboratories announced that it has received approval from the Food and Drug Administration to begin marketing a new medical device for respiratory patients.