FDA Sends Medical Tests as Medical Devices NPRM to OMB

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a notice of proposed rulemaking (NPRM) from the Federal Drug Administration for “Medical Devices; Laboratory Developed Tests”. According to the Spring 2023 Unified Agenda entry for this rulemaking:

“This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.”

It will be interesting to see what portions of the FDA medical device rules will apply to these medical tests. Cybersecurity for testing equipment is one that I would be watching for in these proposed regulations.