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  • Regulatory 'Loophole' Allowing Unsafe Devices to be Marketed, Say Researchers

    • 10 January 2013
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    A "loophole" in the way in which some medical devices are regulated is allowing unsafe devices to reach-and harm-patients, argues a new editorial published in the New England Journal of Medicine . The loophole stems from the 1976 Medical Device Amendments , which established for the first time in the US a system for the regulation of medical devices.  The system classified medical devices into three general categories: Class I for low-risk devices, class II for ...
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    As 510(k) Process Evolves, Questions Remain

    The 510(k) premarket notification process provides a clearance pathway for new, low-risk medical devices to be sold in the US by proving to the US Food and Drug Administration (FDA) that a proposed product is substantially equivalent to another, existing, legally marketed device. But the process has come under fire from critics in Congress and others who have called it a "loophole" that allows devices onto the market without putting them through a rigorous approval proces...
  • Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

    Two legislators have written to the US Food and Drug Administration's (FDA) top medical device regulator, calling on the agency to provide for public access information about medical devices cleared through FDA's 510(k) premarket notification process. The letter , sent 15 August by Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR), observes that several medical devices once cleared through the 510(k) process have been subject to high-profile safety concerns and rec...
  • Congressman Calls for Closure of Medical Device 'Loophole' in Report

    • 26 March 2012
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    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 Fr...