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Consumers Union Urges Congress to Strengthen Medical Device Oversight
Date:11/15/2011

rds of approval for devices from "reasonable assurance" of safety to "substantial evidence" of safety to bring it in line with the standard for drugs.
  • Ensuring that implantable and life-sustaining devices do not go through the 510(k) process - requiring them to go through the full pre-market approval process, which requires clinical trials.
  • Removing recalled devices from the list of predicates upon which other devices may seek to be cleared and requiring that devices approved based on a recalled device be automatically reviewed for safety.
  • Improve current Post-Market Surveillance of devices by:

    • Requiring the FDA to implement a national unique identifier system for devices so that patients and health care providers can be contacted when problems with that device are identified. Currently, there is no universal way to find out which devices went into which patients.
    • Ensuring that the FDA has adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events such as MedWatch, MAUDE and the Sentinel initiative. Used effectively, these programs can help the FDA identify early and ongoing problems with medical devices that are causing harm to patients.
    • Enabling the FDA to use its recall authority more effectively and providing the FDA with authority to call for longer term post market studies and to require device makers to meet their commitments to conduct post market studies.

    Retaining current conflict of interest standards for federal advisory committees.

    Five years ago, consumer organizations, including Consumers Union, advocated strongly for these standards to ensure the integrity of the advisory committee process. Decisions regarding new drugs and devices must be free from even the perception of bias. We question whether any relaxation of these standards is truly needed.

    Finally, in order to ens
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    SOURCE Consumers Union
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