Emergency CMS & FDA Guidance allows Digital Pathology Devices for Remote Diagnosis

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Before  the Covid-19 pandemic, CMS (Centers for Medicare & Medicaid Services) regulations under the 1988 Clinical Laboratory Improvement Amendments (CLIA) restricted pathologists from using digital pathology and other technologies for remote primary diagnosis. Pathologists were required to work within clinical environments (laboratories, hospitals and other healthcare settings) with a valid CLIA license. CMS temporarily suspended those requirements on March 26, enabling pathologists to review cases from remote locations.

On the 24th April, the FDA followed suit, temporarily relaxing requirements for digital pathology devices to encourage clinicians to review scanned images of slides remotely during the coronavirus pandemic.  By lowering the regulatory bar, both agencies hope to prevent any disruption to pathology services and reduce the exposure risk for pathologists. The guidance paves he way for more digital pathology vendors to participate in the market.  The following statement is included in the guidance:

FDA recognizes that greater access to remote digital pathology devices may help facilitate the remote reviewing and reporting of pathology slides during this public health emergency which, in turn, may help facilitate continuity of patient care and reduce healthcare personnel contact and risk of exposure to SARS-CoV-2. For that reason, for the duration of the COVID-19 public health emergency, FDA does not intend to object to:

• modifications to the FDA-cleared indications, functionality, hardware and/or software, of digital pathology devices identified in Table 1 above to provide for use in a remote setting, or

• the marketing of new digital pathology devices of the types identified in Table 1 that are intended for use in remote settings and that are not currently 510(k) cleared for any use, without compliance with the following regulatory requirements, where such devices do not create an undue risk in light of the public health emergency: submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,6 Good Manufacturing Practice requirements in 21 CFR Part 820, and Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20.

Update: The policies are intended to remain in effect for the duration of the public health emergency (PHE) related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary. The PHE was renewed on April 21, 2020, July 23, 2020, October 2, 2020, January 7, 2021, and April 15, 2021, effective April 21, 2021.

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