The group says it is concerned that the draft guidance imposes new reporting requirements that are neither warranted by safety concerns nor authorized by existing statutes and regulations.
By Jim Dickinson
A nonprofit legal organization that champions free enterprise and individual rights is criticizing a recently issued FDA draft guidance on medical device reporting for manufacturers.
The Washington Legal Foundation (WLF) says it is concerned that the draft guidance, issued this past July, imposes new reporting requirements that are neither warranted by safety concerns nor authorized by existing statutes and regulations.
“A major concern among healthcare professionals is that so many medical device reports (MDRs) are required to be filed that the significance of the underlying events cannot be properly analyzed,” the group said in comments to FDA back in January. “WLF is concerned that the proposed guidance does nothing to address that concern and, indeed, exacerbates the problem in several respects. At the very least, before FDA imposes new reporting requirements, it ought to provide a reasoned explanation regarding why it believes those requirements serve the public interest.”
WLF says the guidance states that a malfunction is reportable if “[t]he chance of a death or serious injury occurring as a result of a recurrence of a malfunction is not remote.” However, the Food, Drug, and Cosmetic Act says a malfunction is reportable if recurrence “would be likely to cause or contribute to a death or serious injury.”
The group says a “chance that is ‘likely’ is a far cry from a chance that is ‘not remote,’” and that the draft guidance should be changed to bring it into compliance with its statutory and regulatory mandate.
Jim Dickinson is MD+DI's contributing editor.
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