Devices

Enforcement Discretion on Remote Digital Pathology Devices

FDA has posted a new guidance entitled “Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The document is intended to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides during the pandemic.

FDA says that for the duration of the Covid-19 health emergency, the agency does not intend to object to:

modifications to the FDA-cleared indications, functionality, hardware and/or software, of digital pathology devices to provide for use in a remote setting, or
the marketing of new digital pathology devices of the types that are intended for use in remote settings and that are not currently 510(k) cleared for any use, without compliance with certain regulatory requirements.

Additionally, FDA says that for remote digital pathology devices subject to the policy, it does not intend to enforce compliance with the special controls identified in its regulations.

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