In an effort to speed up and improve postmarket data collection, the FDA recently proposed a new rule that would require manufacturers, importers, and user facilities to submit their medical device reports to the FDA in electronic form, instead of the traditional paper format.
Under the new rule, manufacturers would have to obtain an electronic certificate to use the FDA Electronic Submissions Gateway. They would then be able to choose from two different submission options, suited to the volume of reports they file annually.
The rule would not change what types of incidents are required to be reported to the FDA. The rule would not apply to reports submitted on a voluntary basis.
Information on how to prepare and send postmarket safety reports for devices and for drugs and biologics is contained in draft guidance documents. Visit the FDA’s Web site on electronic medical device reporting for more information.