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Congressman Calls for Closure of Medical Device 'Loophole' in Report

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By Alexander Gaffney

Massachusetts Democrat Edward Markey is calling for the stricter regulation of medical devices and the closure of a so-called “loophole” in the US Food and Drug Administration’s (FDA) 510(k) pathway that currently allows medical devices to be approved even if they are based on a device since recalled for safety defects.

Markey held a press conference on 22 March to both release a report entitled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected From Flawed Medical Devices” and to tout his bill, the Safety Of Untested and New Devices Act (SOUND) of 2012.

Markey said he hopes his legislation will close a “major loophole in the current 510(k) device approval proves,” and added that he wants to see the SOUND Act included in the upcoming Medical Device User Fee Act (MDUFA) legislation that is currently before the House Energy and Commerce Committee.


Read more:

Markey - Markey Joined by Victim, Patient Advocate in Call for Closure of Dangerous Medical Device Loophole

Markey - Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected From Flawed Medical Devices

Boston Globe - Markey targets Boston Scientific and other vaginal mesh manufacturers in new bill




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