The US raised “serious concerns” with several issues regarding the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) and called on the EU to delay MDR/IVDR implementation by three (3) years.
As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the Agency in December 2019 issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single electronic submission.
The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age.
Researchers at the University of Bristol in England are developing a device that mimics the sensitive sense of smell possessed by dogs and other mammals and is capable of sniffing out the faint chemical signatures of chronic diseases.
The FDA announced plans to join two “collaborative communities”—forums comprising public and private stakeholders focused on the development of medical devices—focused on data collaborations and real-world evidence as well as ophthalmic imaging.