- FDA is temporarily relaxing requirements for digital pathology devices to encourage clinicians to review scanned images of slides remotely during the coronavirus pandemic.
- Greater availability of the digital technology could help reduce pathologists' risk of exposure to the coronavirus and prevent disruptions to critical pathology services, FDA said in a COVID-19 guidance document released Friday.
- The new policy follows a decision by CMS in late March to allow pathologists the flexibility to work remotely to review and interpret clinical laboratory data, results and pathology slides during the pandemic.
Before the public health crisis caused by COVID-19, CMS regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 restricted pathologists from making primary diagnoses remotely. The rules required pathologists to work within clinical laboratories, hospitals and other healthcare settings holding a CLIA license. CMS temporarily suspended those requirements on March 26, enabling pathologists to review cases from remote locations.
Philips is a dominant player in the U.S. digital pathology market but faces challenges from Roche, Danaher unit Leica and Sweden's Sectra. Earlier this month, Philips said it received a waiver from FDA that allows pathologists to use consumer monitors at home with the company's IntelliSite Pathology Solution, which previously required a medical-grade monitor. Pathologists are allowed to access images of patient tissue remotely through a secure VPN high-speed internet connection and can make a definitive diagnosis of cases via a web-based browser and monitor meeting specified minimum requirements.
FDA is now looking to increase availability of remote digital pathology devices during the pandemic. The agency has already made a series of similar policy changes to expand access to critical medical devices during the COVID-19 pandemic, including allowing modifications to infusion pumps, and ventilators and other respiratory devices to prevent shortages and promoting greater use of remote patient monitoring technologies to reduce hospital visits and minimize risk of exposure to the coronavirus.
The regulator said it does not plan to object to the marketing of new digital pathology devices intended for remote settings without a 510(k) premarket submission, as long as the technology does not create undue risks. The agency also does not intend to object to modifications to FDA-cleared indications, functionality, hardware or software of digital pathology devices. Further, it does not plan to enforce compliance with special controls covering the content of a premarket submission for a whole slide imaging system.
To avoid risk, FDA recommends companies provide instructions specific to remote use and include in their product labeling information that helps clinical labs and hospitals determine if remote reviewing and reporting of digital pathology slides is feasible with their own information technology infrastructure. A validation study may be necessary, the agency said.
Device instructions should recommend that pathologists use their clinical judgment to determine whether the quality of the images from remote devices is sufficient for their interpretation. Manufacturers should consider evaluating devices in accordance with specific FDA recognized consensus standards, and are also advised to implement appropriate cybersecurity controls to ensure safety and functionality for remote digital pathology devices.