Remote Digital Pathology Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Remote Digital Pathology guidance?
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- Expand access to remote digital pathology devices.
- Facilitate the remote reviewing and reporting of pathology slides.
- Reduce healthcare personnel contact and reduce COVID-19 exposure risk.
What medical device types are covered by this guidance?
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- Digital Pathology devices (Table 1) that have the capability for remote reviewing and reporting of digital pathology slides.
What types of changes to the regulatory process are permitted temporarily?
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- Modifications to the FDA-cleared indications, functionality, hardware and/or software, of digital pathology devices identified in Table 1 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.
What specific FDA regulatory requirements are relaxed temporarily?
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- 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.
- Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20.
- Compliance with special controls identified in 21 CFR 864.1860 and 21 CFR 864.3700 (83 FR 22).
What labeling updates does the FDA recommend for modified devices?
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- Instruct clinical laboratories, hospitals, and other healthcare facilities how to determine if remote reviewing/reporting of digital pathology slides is feasible/appropriate based on their information technology (IT) infrastructure and the remote use environment for individual pathologists.
- Laboratories and hospitals should consider performing a validation study where they deem necessary before remote reviewing and reporting of digital pathology slides at a remote location.
- Instruct pathologists to use their clinical judgment to determine whether image quality from the remote digital pathology devices are sufficient for interpretation of the pathological images.
What is the envisioned validation of COVID-19 changes?
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- Evaluating the device performance should be done according to FDA recognized standards (Table 2).
What are conditions for temporary remote pathology review and reporting laboratory sites?
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- Center for Medicare & Medicaid Service (CMS) issued a memorandum citing following criteria:
- Laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation from HHS.
- Equipment, supplies, and reagents, and other similar items needed at the temporary site are not kept at a temporary testing site on a permanent basis.
- The temporary site complies with other applicable Federal law, including HIPAA.
- The primary site must have a written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel.
- Histopathology slides must be retained for at least 10 years from the date of examination.
- Cytology slide preparations must be retained for at least 5 years from the date of examination.
- Pathology specimen blocks must be retained for at least 2 years from the date of examination.
- Remnants of tissue for pathology examination must be preserved until a diagnosis is made.
- Center for Medicare & Medicaid Service (CMS) issued a memorandum citing following criteria:
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