New Bill Promises To Refine The Lenient 501(k) Medical Device Approval System

Allegedly lenient regulatory practices on behalf of the U.S. Food and Drug Administration (FDA) have allowed several questionable products, most notably transvaginal mesh, to reach interstate commerce. The ambiguity of such regulatory practices has demonstrated a propensity for the release of potentially dangerous devices on the U.S. market. However, a bill recently proposed by the Democrats promises to prevent the release of dangerous medical devices based on past products with established safety issues. Subsequently, the bill would close a loophole that lets devices win approval even when they’re similar to a product already pulled from the market.

Transvaginal mesh devices spurred an FDA alert last year after an influx of complaints and injuries was witnessed in those who received the vaginal implants. The increase in adverse events regarding the surgical application of transvaginal mesh devices in the treatment of stress urinary incontinence (SUI) became the subject of intense scrutiny. An FDA Executive Summary containing the Manufacturer and User Device Experience (MAUDE) database identified 1,371 adverse event reports related to mesh devices used to treat SUI between 2008 and 2010. Included in the reports were three deaths, 1,131 injuries, 236 malfunctions, and one particular event conspicuously labeled “other.”

The devices were cleared by the agency’s 510(k) system, which allowed them to be sold without human testing once the FDA ruled that they were similar to products that had already been released. “510K” refers to the Medical Device Amendment (MDA) of 1976 in which statutory provisions granted the FDA the authority to make exceptions for post-1976 medical devices that the Agency deemed “substantially equivalent” to older products. Essentially, the 510(k) system allows manufacturers to market devices without pre-market testing, or formal FDA approval, if the manufacturer can prove their new product exhibit “substantially equivalent” characteristics to those of the ones already on the market. That is so even if the “old” product was itself never tested or approved by FDA. What’s worse is that, as it happened, the vast majority of products introduced to the market since 1976 have fallen into this 510K “loophole,” so that most medical devices sold today have never been tested in compliance with the pre-market testing requirements of the MDA, nor have they been formally “approved” by FDA. Such ambiguous practices have result in countless transvaginal mesh lawsuits leveled at the manufacturers.

However, a new bill proposed by Democrats promises to close the loophole created in the 510(k) system. Subsequently, the bill would ensure that devices do not continue with the mistake-ridden tradition they are currently on. The proposed legislation, otherwise known as Markey’s bill, would allow the FDA to reject devices that are grandfathered in under the 510(k)system if the previous products were recalled or are in the process of being recalled. It also would require companies to explain why their products are different from recalled versions. In addition, the bill would require the FDA to review previously cleared products to determine whether any have recalls in their “device lineage.” Doing so would acknowledge the flaws associated with the 510)k) system.

Markey’s bill is one of more than a dozen introduced in Congress to overhaul device reviews, in response to consumer advocates who say products need to be safer and industry groups who say the process is too strict.

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