WASHINGTON, Aug 3 (Reuters) - Makers of some medical devices would have to supply more information before they could be considered for the U.S. market under reforms proposed by regulators that include changes to a controversial process that can speed approval.
The accelerated 510(k) process has drawn fire from critics that say it is too widely used, but it is defended by industry as necessary to keep up with ever-evolving technology.
In a nearly 200-page report released late Tuesday, the Food and Drug Administration proposed changes that include creating a subset of moderately risky devices, such as infusion pumps, that would typically need to be accompanied by more data.
Currently, such Class 2 devices can be approved if their makers can show they are "substantially equivalent" to another device already on the market.
The FDA's Center for Devices and Radiological Health (CDRH) said the overall device revamp will help fix an unpredictable system plagued by lengthy delays and inefficiencies.
The recommendations "represent a blueprint for a smarter medical device oversight with the tools CDRH needs to drive innovation ... while continuing to assure the safety and efficacy of medical devices," said Jeffrey Shuren, director of the FDA's device center.
Advanced Medical Technology Association (AdvaMed), the industry's lobby group, said it was pleased with some of the steps aimed at improving reviews but that the overhaul itself could cause problems.
"There are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years," AdvaMed President and CEO Stephen Ubl said. "We believe changes should be targeted, have a corresponding public health benefit and not undermine a system that has a remarkable safety record."
But Diana Zuckerman, a strong critic of the FDA's device oversight, called the proposal "a mixed bag" for consumers.
Despite its "rather dramatic statements" acknowledging big problems, its impact depends on whether the FDA takes strong steps to fix them, said Zuckerman, president of the National Research Center for Women & Families.
The proposal follows a shake-up of the FDA's device unit under President Barack Obama that has included replacing the device unit's former chief[#msg-40505505, #msg-45762877] and calling for an outside review by the independent Institute of Medicine (IOM).
On Tuesday, the FDA also announced it has appointed an outspoken device critic, William Maisel, as the device center's chief scientist and a deputy director. Maisel, a Beth Israel Deaconess Medical Center cardiologist, has denounced FDA's device oversight and urged more consumer safeguards.
The FDA called for much more information on FDA-approved devices to be made public, including photographs and diagrams. A new database would offer public access to agency review decisions and device labeling.
The agency also plans to clarify how and when it can pull a 510(k)-approved device off the market. The agency has not publicly named the roughly 100 such devices it has removed over the last 30 years, but officials said they have included an artificial hip and a condom that were not backed up by data.
The agency will weigh public comments on its proposal for 60 days before deciding which changes to adopt. FDA's Shuren said more controversial moves will be put on hold until the IOM can review them as part of its report, expected in mid-2011.‹
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