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Case Detail


In re: MMDA Petition on 510(k) Medical Device Evaluation
(Regulatory Proceeding)
On October 16, 2013, WLF filed formal comments with the Food and Drug Administration (FDA), urging the agency to grant the relief sought in a Citizen Petition filed by the Minnesota Medical Device Association. The Petition criticized recent changes in the manner in which FDA administers the “510(k) process,” the process by which most medical devices are cleared for marketing. WLF’s submission agreed with those criticism, noting that the 510(k) process is being transformed from one in which FDA examined whether a new device was as safe as existing devices, into one in which FDA evaluates whether the device meets some absolute level of safety. WLF argued that FDA’s policies threaten America’s leadership in medical device innovation; it noted that FDA product clearance can take so long that American consumers often do not gain access to innovative products until several years later than their European counterparts. WLF asked FDA to rescind a recent 510(k) guidance document.
Case Status:
Awaiting FDA action.
More Information and Downloads:
10/16/2013: Download the Comments

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