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The Over-Regulation of Digital Pathology Systems

By Richard Morroney, RAC, CQA

Why does it take a pandemic to reset overly burdensome medical device regulations?

Whole slide imaging (WSI) system technology is not new. These devices have been used in major world markets for over twenty years. The Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) regulate WSI systems as in-vitro diagnostic devices (IVDs). The host of burdensome special controls levied by those regulatory bodies has limited the use of such devices to clinical labs and other healthcare settings that are Clinical Laboratory Improvement Amendments (CLIA) certified.

Both agencies have issued enforcement discretion policies due to the COVID-19 pandemic:

  • On March 26, 2020, CMS issued a temporary CLIA regulatory waiver indicating that CMS will exercise enforcement discretion to existing CLIA regulations to facilitate pathologists’ ability to review pathology slides remotely for those laboratories that are using validated whole slide imaging systems for primary diagnosis.

The fact enforcement discretion was required to ease the burden on pathologists during the pandemic suggests that WSI systems may be over-regulated.

FDA now believes that WSI systems will not create undue risk as long as i) device hardware meets recognized consensus standards for electrical safety and ii) appropriate labeling is present recommending that pathologists use their clinical judgment to determine whether the quality of the images is sufficient for interpretation. In other words, FDA considers such systems safe enough to ignore its own stringent premarket notification regulations.

The fact of the matter is that pathologists won’t use WSI systems if image quality is insufficient to render a diagnosis or is otherwise unsafe. Device labeling itself requires that pathologists use a microscope in the event of poor image quality.

Moreover, CMS agrees pathologists can safely sign-out cases remotely using their professional judgment provided that the WSI system is validated by the lab.

If WSI systems are validated by labs and their usage is controlled by CLIA regulations, why do we need FDA premarket regulations which require validation?

Having overlapping regulations isn’t going to make WSI systems safer and more effective. It is unclear what benefits are derived by having both FDA and CMS regulations. What is clear, however, is that over-regulation has been a barrier to adoption of this important technology and is contrary to FDA's mission of advancing the public health by helping to speed innovations that make medical products safer, more effective, and more affordable.

I believe that FDA should abide by its commitment to the least burdensome approach of ensuring medical device safety and efficacy. Consequently, FDA should regulate WSI systems as class I devices. CLIA regulations and pathologists' judgment are sufficient to govern the safe use of low-risk WSI systems for primary diagnosis.

Tags: digital pathology, regulation, FDA, CMS, CLIA