FDA News

Breast Implants Highlight Medical Device Safety Tracking Issues

To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually – a tiny fraction of the hundreds of thousands of implant surgeries …

FDA Plans to Overhaul Medical Device Approval System

US health officials said Monday they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical instruments. The Food and Drug …

Spinal-Cord Stimulators Present Problems for Some Patients

Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life. It wouldn’t fix the nerve damage in his mangled right arm, Taft and his wife …

FDA Crack’s Down on Menthol Cigarettes, Flavored Vapes

In a major new effort to curb smoking, a top U.S. health official pledged Thursday to try to ban menthol cigarettes and flavored cigars and tighten rules governing the sale of most flavored versions of electronic cigarettes. The proposed restrictions …

FDA Bans Some Artificial Flavors Due to Safety

Six artificial flavors are being ordered out of the food supply in a dispute over their safety, but good luck to anyone who wants to know which cookies, candies or drinks they’re in. The dispute highlights the complex rules that …

FDA Approves Powerful Opioid Pill as Alternative to IV Painkiller

U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. The decision by the Food and Drug Administration came over objections from critics who fear the pill will be abused. In …

Federal Agencies Clash on Cellphone Cancer Risk

Two U.S. government agencies are giving conflicting interpretations of a safety study on cellphone radiation: One says it causes cancer in rats. The other says there’s no reason for people to worry. No new research was issued Thursday. Instead, the …

Forgoing Recalls, Med Device Firms Sometimes Use Doctors to Screen for Defects

Results of a new behavioral study into what influences the decision to recall a defective product found that medical device firm managers may rely on their physician-customers to screen out detectable defects, in lieu of issuing a recall. The study …

Autopsy Confirms Exploding Vape Pen Killed Florida Man

An exploding vape pen hurled fragments into a Florida man’s head, killing him and starting a fire that burned most of his body, an autopsy report said. The Pinellas-Pasco Medical Examiner’s autopsy report released Tuesday confirms the vape pen was …

Rodent Infestation, Filth Found Before Egg Recall

Before a U.S. farm voluntarily recalled 207 million eggs, government inspectors found rodents scurrying in manure pits, equipment that was coated with grime and food debris, and outside a swarm of “large flying insects too numerous to count.” Unsanitary conditions …