FDA Asks for Outside Review of Expedited Medical Device Approvals

The Food and Drug Administration wants an outside panel of medical advisers to examine the agency’s policy of approving certain types of medical devices without subjecting the products to the same level of scrutiny as other devices.

The Institute of Medicine, a nonprofit body made up of the government’s top medical advisers, will take the next two years and spend about $1.3 million to review the FDA’s system for approving devices that are deemed similar to those already on the market – a process that is called a 510k review.

The expert panel plans to hold a series of public hearings in the coming months to gather input from physicians and other medical industry professionals. A formal report on its findings is expected in March 2011, the FDA said.

Expedited Review Process Subject to Abuse

Under a 510k review, medical device makers seek expedited approvals to launch devices that are essentially the same as those already approved. However, critics including Congressional leaders and product-safety advocates have said the FDA’s quicker-than-normal approval process is subject to abuse and misuse, which puts patients at risk of defectively dangerous medical devices.

“I have long been concerned that the 510k process permits too many devices on the market about whose safety and effectiveness even the FDA is uncertain,” said Rep. Henry Waxman (D-Ca.), chairman of the House Energy and Commerce Committee, which oversees the FDA, according to an Associated Press report. “The result is hundreds of recalls of important devices for serious safety concerns.”

The FDA originally said the 510K review process was meant to speed up approvals of simple devices, such as bandages and wheelchairs, which are considered advancements on already approved products. However, much more complicated medical devices like hip replacements and heart implants, which post considerably greater risks of injury to patients, have been granted expedited approvals under the process, critics say.

The Government Accountability Office, which serves as the investigative arm of Congress, recently identified 24 types of medical devices that were approved without close scrutiny under the FDA’s streamlined 510k approvals process.

The FDA said in a statement that medical technology has changed quickly in recent decades “making it an appropriate time … to review the adequacy of the pre-market notification program,” the AP reports.

Companies that receive 510k approvals do not have to submit to the FDA results of large patient studies before launching their devices. Instead, the medical device makers claim that their devices are similar to other FDA-approved products and do not need to undergo the stringent FDA review and approval process.

Instead of waiting years for the FDA go-ahead, companies moving forward under the 510k system typically get an answer from the agency within 90 days.

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