Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.) and Rosa DeLauro (D-Conn.) have introduced legislation that would give the Food and Drug Administration authority to reject 510(k) applications of medical devices that are similar to ones that have been recalled for causing serious harm to patients.
Currently, the FDA is able to clear a device based on its similarity to a product that is already on the market, known as a "predicate." The federal agency, however, does not have the power to block the introduction of medical devices that are similar to recalled devices. The legislation was penned in response to injuries incurred from transvaginal implants manufactured by Johnson & Johnson and C.R. Bard.
The Safety of Untested and New Devices Act of 2012 includes other provisions:
• Requires companies to inform FDA if any products in their new device's "predicate lineage" have caused serious harm and to explain how theirs avoids past mistakes.
• Instructs FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate.
• Strengthens reporting requirements so that companies and the public can easily determine why a recall occurred.
• Calls for FDA to review the safety of high-risk devices if a product in their "predicate lineage" is recalled due to major safety problems.
Currently, the FDA is able to clear a device based on its similarity to a product that is already on the market, known as a "predicate." The federal agency, however, does not have the power to block the introduction of medical devices that are similar to recalled devices. The legislation was penned in response to injuries incurred from transvaginal implants manufactured by Johnson & Johnson and C.R. Bard.
The Safety of Untested and New Devices Act of 2012 includes other provisions:
• Requires companies to inform FDA if any products in their new device's "predicate lineage" have caused serious harm and to explain how theirs avoids past mistakes.
• Instructs FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate.
• Strengthens reporting requirements so that companies and the public can easily determine why a recall occurred.
• Calls for FDA to review the safety of high-risk devices if a product in their "predicate lineage" is recalled due to major safety problems.
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