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Case Detail


In re FDA Medical Device Reporting
On October 11, 2013, WLF filed formal comments with the Food and Drug Administration (FDA), urging the agency to withdraw a proposed Guidance document regarding when medical device manufacturers are required to report a malfunction of one of its products. WLF asserted that FDA is requiring so many medical device reports (MDRs) to be filed that the significance of the underlying events cannot be properly analyzed. WLF stated that the proposed Guidance does nothing to address that concern and, indeed, exacerbates the problem in several respects. In particular, WLF charged that FDA continues to ignore a statute, adopted by Congress six years ago, that requires FDA to streamline the MDR reporting requirements for all but the most complex medical devices. WLF also argued that FDA should refrain from requiring multiple companies to maintain reporting responsibilities for a single device.
Case Status:
Awaiting FDA action.
More Information and Downloads:
10/11/2013: Download the Comments

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