When COVID-19 surprised us in early 2020, digital pathology providers had few FDA-cleared options to leverage their solutions, even though they were ideally suited to the new era of social distancing. Fortunately, welcome reprieve came by way of temporary waivers of the FDA's 510(k) premarket notification requirements, which enabled pathologists to work and diagnose patients remotely, often from the safety of their homes. (For a refresher on those developments, please take a look at my June 5th 2020 blog post.)
In exciting recent news, the FDA has proposed that these regulatory flexibilities be made permanent. This will eliminate the need for 510(k) requirements, enabling Inspirata’s digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity.
In essence, the global pandemic presented a unique opportunity for the FDA to evaluate adverse events prior to and during this health crisis. Thanks to the low number of adverse events registered by several medical devices in its Manufacturer and User Facility Device Experience (MAUDE) database over the last 10 years, the FDA determined that the 510(k) premarket notification did not provide additional safety and efficacy benefits. In fact, digital pathology image viewing and management software registered zero adverse effects during both periods.
With this new pronouncement in favor of less regulation, the government is now effectively affirming that digital pathology no longer required premarket notifications. In fact, it puts the technology on a level playing field with traditional microscopy in terms of safety and efficacy. This speaks volumes to the maturity that digital pathology has attained, further driving increased confidence and momentum in the field. We expect this to translate into more rapid adoption of digital diagnoses for practitioners at all types of pathology labs.
The continued validation and decreased regulation of digital pathology represent a key turning point in the rise of this important field.