COVID-19 Tests and Collection Kits Authorized by the FDA
The FDA has authorized over 300 tests and sample collection devices, including a wide variety of tests for use in a range of settings.
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreThe FDA has authorized over 300 tests and sample collection devices, including a wide variety of tests for use in a range of settings.
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
This infographic provides a visualization of data associated with CDRH's unprecedented response to the pandemic in 2020.
Dec 29 – The FDA takes new actions to increase the safety of laparoscopic power morcellators used in gynecologic procedures.
Dec 23 – First device authorized to treat patients with necrotic tissue resulting from acute pancreatitis complications.
Dec 18 – First implant system for adults who have above-the-knee amputations and cannot use a conventional prothesis.
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.