Alicia Mundy and Jon Kamp, Wall Street Journal: February 15, 2011
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.
The study by a Washington health-research group and the Cleveland Clinic’s Steven Nissen comes after the Food and Drug Administration proposed changes to tighten the faster approval system, known as 510(k), but put off some of its toughest proposals for further study under pressure from device makers.
Of 113 medical devices that were subject to recalls between 2005 and 2009, 80 were allowed on the market through the 510(k) program, the study found. About a third of the recalled devices were cardiovascular products, including several brands of external defibrillators.
“These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices,” said the authors. The lead author, Diana Zuckerman, heads the National Research Center for Women & Families, a group that has advocated stiffer approval standards for medical devices.
The 510(k) process is popular with the industry because it can save time and money in regulatory reviews, and industry lobbyists have been campaigning on Capitol Hill against radical revisions to the program.
The process requires that the proposed device be similar to a product already marketed, and is intended for low and moderate-risk devices.
The industry’s lobbying group, the Advanced Medical Technology Association, or AdvaMed, said the study is flawed because it looks at the number of recalls without comparing that to the number of devices that didn’t have problems. AdvaMed-supported studies say that more than 99% of the devices cleared through 510(k) don’t face recalls.
Overall, the 510(k) program has a “remarkable safety record with extremely low recall rates,” AdvaMed said. […]
A 510(k) costs the FDA an average of about $20,000 per application compared to more than $800,000 for a full device review by the agency, according to the report. A full review includes evaluation of safety-and-efficacy clinical trials. […]
Read the original article here.