We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A legislative discussion draft being floated in Congress would require the FDA to develop one set of regulations governing both in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) — to create a more predictable and timely path to market. Read More
Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies, says new guidance from the UK’s MHRA. Read More
The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures. Read More
Australia’s Therapeutic Goods Administration (TGA) is proposing to review products currently classified as Class I medical devices to see if they should be reclassified as consumer goods. Read More