The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More
Becton, Dickinson has entered into an agreement with the state of Georgia to settle litigation by the state’s Attorney General aimed at temporarily stopping BD from operating its Covington medical device sterilization facility. Read More
The A-list draft guidance for the year ahead include guidances on breast implants, premarket submissions for managing cybersecurity and distinguishing between device servicing and remanufacturing. Read More