Study: Expedited Medical Device Reviews Account For Majority Of Recalls
The analysis, which was published in the Archives of Internal Medicine, connected the Food and Drug Administration's most urgent medical device recalls with high-risk devices that were subject to "speedy" review.
Los Angeles Times: Most Recalled Medical Devices Received Speedy FDA Review
A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths - including external defibrillators and insulin infusion pumps - were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls (Zajac, 2/15).
The Wall Street Journal: Device Review Process Faulted
Most of the medical devices recalled in recent years because of serious or life-threatening hazards were initially cleared for market through an abbreviated approval system that doesn't require testing on patients, according to a study in the Archives of Internal Medicine (Mundy and Kamp, 2/15).
NPR: Risky Medical Devices Untested In Patients Account For Many Recalls
A study in the Archives of Internal Medicine notes that many of the most critical medical devices are allowed on the market without their makers being required to submit results of clinical studies before approval. And, the analysis finds, most of the Food and Drug Administration's most urgent recalls in recent years have involved "high-risk" devices that had gone to market that way. ... The reason so many devices get waved through the 510(k) process is clear enough. The FDA doesn't have the staff or budget to do pre-market reviews on the vast majority of new devices submitted each year (Knox, 2/14).
Reuters: Device Recalls Linked To Quicker FDA Review
Most medical devices recalled for serious health risks were cleared after a quicker type of U.S. government review that usually requires no testing in people, U.S. researchers said on Monday. The team -- led by consumer advocates and Cleveland Clinic cardiologist Steven Nissen, an outspoken critic of government oversight of product safety -- said the findings showed the need for more testing of risky products. An industry group and the Food and Drug Administration defended the quicker review method, saying thousands of patients had benefited and only a tiny fraction of the products were recalled (Richwine, 2/14).
Star Tribune: Study Calls For More FDA Scrutiny Of Medical Devices
A new study of medical devices that were recalled by regulators for serious safety issues found many had been approved by regulators through a controversial pathway that usually doesn't require rigorous studies to prove safety and effectiveness. The study, published online Monday by the Journal of the American Medical Association, prompted a vociferous exchange between industry group AdvaMed and the lead author, Dr. Diana Zuckerman of the National Research Center for Women & Families (Moore, 2/14).