The CAP urged the Food and Drug Administration (FDA) to cautiously proceed with new regulations and increase flexibility for digital pathology devices under premarket notification requirements. In a March 15 letter to the agency, the CAP cautioned against moving forward with three of four digital pathology product codes because it may result in unintended consequences such as issues with lack of standardization and interoperability, and increased physician liability. At the same time, the CAP encouraged the FDA to consider the affects that digital pathology system waivers for whole slide imaging systems and management software may have on artificial intelligence tools in the future.

The CAP has advocated for reductions in regulatory burdens. In the March 15 letter, the CAP said regulatory flexibility should include a framework that can assess the totality of an open system, including the impact of individual components that may be waived. There should also be parameters to monitor and adjudicate whether waivers are appropriate.

During the pandemic, the FDA issued temporary waivers for premarket notification requirements. The CAP said it considers making waivers permanent for three of the four digital pathology product codes (QKQ, PSY, and OEO) to be premature.

“In addition, the deregulation of digital pathology components and systems should be based on robust data that are more extensive and transparent,” the CAP said in the letter. “This regulatory decision was made based on the Manufacturer and User Facility Device Experience database (MAUDE) in which medical device reports (MDRs) are submitted to the FDA by mandatory reports (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients, and consumers. For digital pathology codes, MAUDE reports three total adverse event reports none of which include any death related incidents within the last ten years.”

The current data suggest it is inadequate to assess risk the systems pose. According to a September CAP survey, 5.4% of laboratories surveyed reported using whole slide imaging systems during the public health emergency.

In addition to the CAP’s own comments, the Association for Pathology Informatics also sent a letter that was supported by the CAP, the American Society for Clinical Pathology, the Association of Directors of Anatomic and Surgical Pathology, and the Association of Pathology Chairs. The groups supported the continued FDA oversight with varying degrees for the digital pathology product codes QKQ, PSY, and OEO. However, the groups asked that the digital pathology product code PZZ (digital pathology display) be no longer required.