FDA Takes Aim at 510(K) Medical Device Approvals

Thousands of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices are approved every year in the U.S. without proof of efficacy. The U.S. Food and Drug Administration (FDA) had always defended this process, commonly known as known as 510(k) approvals, claiming it promotes innovation. Now, under proposed reforms, some device makers might have to provide more information before their devices would be considered for approval, writes Reuters.

The FDA’s policy of fast-tracking medical devices contrasts greatly with its process for drug approvals. The FDA requires new medications be studied in thousands of people to determine safety and efficacy prior to approval for market release. By contrast, medical device makers must simply demonstrate a device does what they claim, and that it poses no undue safety risks. Unlike a new drug, a device approved under 510(k) does not have to prove efficacy.

Many have criticized the fast-tracking process saying it is over-used, says Reuters; industry, as expected, argues that fast-tracking is needed to match technology. Now, in an extensive report released late yesterday, the FDA proposed enhancements such as the creation of a sub-set of “moderately risky devices,” that calls for additional information, according to Reuters. Today, these Class 2 devices receive approval if they can be shown to be “substantially equivalent” to an already approved device.

This and other 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, quoted Reuters. There are roughly 70 proposed changes.

Also proposed are for data on FDA-approved devices to be publicized with photographs and diagrams; implementation of a new database with public access to FDA review decisions and device labeling; and clarification of how and when 510(k)-approved device can be removed from the market, says Reuters. Although the FDA has not released the names of the 100 devices pulled in the past three decades, officials said an artificial hip and a condom not “backed up by data” were pulled, says Reuters.

We have written on several occasions and Reuters noted that massive changes took place at the agency following the administration re-vamp under President Barack Obama, which included replacing the former device unit chief. Yesterday, the FDA announced it appointed William Maisel as its device center’s chief scientist and deputy director, writes Reuters, which described Maisel as an “outspoken device critic.”

We recently wrote that advocacy group Public Citizen revealed eight significant loopholes in how the FDA approves medical devices, allowing potentially unsafe, ineffective, dangerous products on the market, said Health Leaders Media.

Worse, as we have also previously written, some 510(k)-approved medical devices have been found to be defective. Protegen, a synthetic sling implanted under a woman’s bladder to prevent stress incontinence was granted 510(k) approval in 1996, but was recalled three years later due to a high rate of complications. Medtronic Inc. recalled its Sprint Fidelis defibrillator lead, approved under the 510(k) process, after it was found to have a higher-than-normal facture rate and was implicated in five deaths.

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