The FDA has proposed a new draft guidance outlining what manufacturers should do when they become aware of a potential medical device shortage during a public health emergency.
The FDA is warning that a form of heart surgery used to treat atrial fibrillation appears to carry greater health risks for women than men.
Medical device manufacturers often fail to report patient deaths as deaths, distorting the FDA's view on the safety profile of those devices, which could continue to put patients at risk,…
While federal regulatory agencies continue to limit travel during the COVID-19 pandemic, a new government watchdog report warns that the U.S. Food and Drug Administration (FDA) has fallen even further…
The FDA warns that pulse oximeters may be more inaccurate when used on people of darker skin.
The FDA warns patients who received Endologix AFX Endovascular graft systems follow up with their doctor annually due to the risk of endoleaks which could cause health complications.
The FDA plans to hold a virtual meeting in November to discuss with the public ways to improve its medical device safety warnings.
The FDA warns of potential injuries from hot and cold therapy devices if instructions are not closely followed.
The FDA is advising doctors to have patients go through a trial period before permanently implanting a spinal cord stimulator for pain management.
The FDA warns that some generic EpiPens may deliver an overdose of epinephrine due to a missing component.