New Rules Are Issued for Testing of Medical Devices

(New York Times) – The Food and Drug Administration said Thursday that it was toughening testing procedures for manufacturers of reusable medical devices. It issued the new requirements in the wake of news that two people in a Los Angeles hospital had died from a deadly bacteria traced to medical scopes. The changes will apply to new devices that the F.D.A. approves, not to the ones on the market that have led to the infections.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.