Producers of remote digital pathology devices, which allow for the review of patient images, will be temporarily exempted from most regulatory requirements by the FDA in a development intended to help allow health care workers to reduce their exposure to patients with COVID-19.
By Laura DiAngelo, MPH
How Things Work Now
Medical devices are typically subject to regulatory review by the FDA before gaining market access, unless otherwise exempted. This applies both in cases where a device is new to market and when a manufacturer makes “significant” updates to an existing device. Significant changes may include the use of a new material, an update to the product’s intended use, a change to its manufacturing process, or a new digital or wireless capability.
In these circumstances, the manufacturer is required to submit a supplement to the FDA for its review or clearance. This policy is intended to ensure that any changes to the device do not alter the product’s function beyond the scope of its original approval or clearance, and that no patients are potentially harmed by the changes.
However, during the ongoing COVID-19 public health emergency, the FDA has recently taken action to reduce these regulatory hurdles, specifically for changes to a device’s functionality that will allow health care providers to remain physically distant from their patients to lessen the risk of exposure to patients with COVID-19.
On April 24, the FDA issued new guidance allowing changes to the claims and functionality of remote digital pathology devices, which are medical devices that allow providers to view scanned digital images of pathology slides, rather than having to look at them in person. These devices are regulated as Class II, or “moderate risk,” devices, which means that they are regulated under the 510(k) premarket notification pathway.
Typically, these products are used in health care settings or facilities, such as clinical laboratories or hospitals. However, under the guidance, the FDA will not take action against manufacturers of certain remote digital pathology devices when altering their products to add functions to facilitate their use in remote locations, or marketing new devices that have not been 510(k) cleared.
The FDA’s action aligns with similar guidance issued in March 2020 by CMS, which allowed the review of pathology slides and images remotely, rather than in a certified clinical laboratory.
The scope of the guidance includes devices regulated under product codes OEO (automated digital image manual interpretation microscope), PSY (whole slide imaging system), QKQ (digital pathology image viewing and management software), and PZZ (digital pathology display).
Under the policy, the devices that have been altered or introduced to market will not be subject to several requirements, including premarket notification requirements, good manufacturing practice requirements, and Unique Device Identification (UDI) requirements, which allow products to be tracked through the market. Additionally, the special controls to which these devices are typically subject will not be enforced for the duration of the emergency.
The FDA has released a spate of guidance documents intended to increase the availability of devices intended to be used by health care providers to remotely care for COVID-19 patients. The new guidance is intended to be used along with CMS’s memorandum to help increase the ability of pathologists to review pathology slides and images remotely using remote pathology devices.
Although remote pathology devices distributed under the guidance would need to be pulled from market after the conclusion of the emergency, it’s not clear that the FDA will be able to ensure that all of them are—raising patient safety concerns as well as manufacturer liability.
It’s also not clear if companies would want to go through the challenges of bringing a new device to market if they would only have to remove them after an unknown period of time. While the FDA’s guidance permit a product to come to market, it does not absolve the company of legal liability.