A recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing quality to rush products to market.
Article preview from "The Gray Sheet"- May 24, 2010
A recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing quality to rush products to market.
"We're concerned because we have seen a substantial increase in the number of recalls over the last few years," Steve Silverman, senior advisor to the CDRH director, said May 5 at the MedCon medical device conference in Cincinnati.
"Perhaps even more troubling is that there has been a major jump in Class I recalls," he added. "Since the beginning of this fiscal year [which began Oct. 1, 2009], we have designated almost 30 recalls as Class I. That is nearly as many Class I recalls as we saw in all of fiscal year 2009."
Class I is FDA's most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death from use of the defective products.
Silverman said CDRH is trying to better understand why so many recalls are happening.
"There are a number of possible causes," he said. "Part of it is increased agency attention to this area, and holding firms more accountable for product problems more closely and more cautiously than we have in the past. Part of it may be a lack of understanding on the part of some manufacturers about our expectations."
However, it also "may be a lack of willingness on the part of firms to slow the process of bringing products to market in favor of making sure that those products, once marketed, will work in the manner in which they're designed to work," Silverman said.
"It's unacceptable to finish products in the marketplace. That's not the way the regulatory system works," he said.
Editor's note: For more on Class I recalls, as well as in-depth information on human factors and FDA's new home-use device initiative, see the May 2010 issue of "The Silver Sheet," Elsevier Business Intelligence's monthly newsletter on device quality and compliance issues. For a free trial, call 1-800-332-2181.
- Shawn M. Schmitt
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