FDA Weighs Classifying EHRs as Medical Devices

The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records (EHRs) as medical devices as it develops new rules targeting software, according to Center for Devices and Radiological Health (CDRH) director Dr. Jeffrey Shuren.

Healthcare Informatix reports that Shuren discussed the agency’s deliberations on EHRs April 7 at the PharmEHR Summit in Philadelphia. Given that the FDA has already begun regulating some software products as well as mobile medical applications, extending its reach to EHRs should at least be considered, argued the director.

If EHRs ultimately do fall under the CDRH’s purview, that could entail regulatory reviews of EHR providers’ manufacturing processes and design controls plus verification testing. As these products become more sophisticated and interface with more and more devices already under FDA regulation, Shuren said, EHR interoperability issues will have to be addressed and integration standards set regardless of whether the CDRH or some other regulator ends up overseeing them.

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