MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food & Drug Administration’s medical device application review, finding that application times jumped 37 percent from 2006 to 2010.
Emergo reviewed the number of submissions the FDA clears each year and how long it takes to win 510(k) clearance to obtain an average "submission to clearance" time.
In 2006 510(k) applications cleared by the FDA took an average of 96 days, but that number jumped to 132 days in 2010.
More than 53 percent of 510(k) submissions from January 1, 2006, to May 23, 2010, were cleared within three months, and more than 80 percent made it through within six months, according to the report.
"One possible explanation may be that FDA reviewers are requesting more clinical performance data from a higher percentage of manufacturers submitting 510(k) applications," Emergo VP of global marketing told Medical Device and Diagnostic Industry news. "This would, in turn, lead to an overall increase in 510(k) clearance times because manufacturers need to respond to those additional requests from the FDA."
Are FDA criticisms all spin and no science?
A steady stream of studies criticizing the FDA’s medical device review process have emerged lately, enough to lead Jeffrey Shuren, director for the Center for Devices and Radiological Health, to say that the frequent jabs have brought down employee morale.
The critical studies surround the 510(k) review process as the agency considers changes that may mean more regulation for the industry, but challengers say the studies are biased.
Most of the studies are funded by med tech companies, and challengers say that studies not funded by the industry come to very different conclusions, the Star Tribune reported.
AMA stays behind individual mandate
The American Medical Assn.’s House of Delegates voted to support the individual health insurance mandate in President Barack Obama’s health care overhaul.
The motion passed the the country’s largest physician trade association with overwhelming support, winning 326-165.
The delegates voted down a proposal that each state decide its own position on the mandate, Healthwatch reported.
Bariatric surgery for weight-loss may affect fertility
Following a recent study that found that bariatric surgery didn’t improve survival in older, severely obese patients, new data presented at the American Society for Metabolic & Bariatric Surgery in Orlando, Fla. found that bariatric surgery may have helped restore fertility in some extremely obese women.
Researchers studied medical records for 566 extremely obese women who underwent the weight-loss surgery over a period of nine years, including 31 who had been diagnosed with polycystic ovarian syndrome, a hormonal imbalance that made them incapable of having children.
Out of the 31 women with PCOS, the six who were pre-menopausal and said they wanted to start families were able to conceive within three years of their gastric bypass surgery, the New York Times reported.