FDA Loosens Regulations on Digital Pathology Devices During Outbreak

To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories.

The agency said in an emergency final guidance that it will permit clinical laboratories to make modifications to those devices to allow their use remotely for reviewing and reporting slides.

The FDA “recognizes that greater access to remote digital pathology devices may help facilitate the remote reviewing and reporting of pathology slides during this public health” crisis, the agency said.

The devices covered by the new policy include:

• Automated digital image manual interpretation microscopes;
• Whole slide imaging systems;
• Digital pathology image viewing and management software; and
• Digital pathology displays.

Under the temporary policy, these types of devices may also be marketed when they are intended for use in remote settings and lack 510(k) clearance.

The guidance includes labeling recommendations. For example, the devices should come with instructions for laboratories, hospitals and other healthcare facilities to help them determine if reviewing and reporting digital slides remotely is practical given their information technology infrastructures and remote-use environments. Before remote reviewing and reporting, validation studies should be conducted where necessary, the agency said.

Labeling should also instruct pathologists to use their clinical judgment in determining if the quality of the images is adequate.

Read the emergency guidance here: www.fdanews.com/04-24-20-COVID19DigitalPathologyGuidance.pdf. — James Miessler