Dear Community: The FDA is Taking Enforcement Action for Noncompliance

The Agency recently issued a Warning Letter for a wearable cardiac monitoring device that it determined to be adulterated and misbranded in violation of the Federal Food, Drug & Cosmetic Act. The FDA found that the manufacturer had changed its intended use and the algorithm design without obtaining a new market authorization. Further, the FDA found the instructions for use to be inadequate because it failed to provide important information about the functionality of the product (particularly related to limits on data collection/transmission for review) to the clinician and patient. Finally, the Agency identified several deficiencies in the Quality System, particularly related to CAPAs, complaint handling, adverse event reporting (specifically related to two deaths and significant cardiac events).

This should be a major warning to Medical Device manufacturers, especially SaMD and Digital Therapeutics developers (including those who rely on AI and ML technologies). It would be foolish to be lulled into the thinking that, because it's so easy to make changes to software, a new market authorization is not required. Simplicity and speed of a change has no bearing on the legal requirement to obtain market authorization from the FDA prior to implementing the change.

This should also be a major warning about engagement with the FDA when it comes to addressing the Agency's concerns. The Warning Letter notes seven monthly communications between the manufacturer and the FDA before the Warning Letter was issued. How you engage with the Agency can significantly affect the outcome of your engagement. Having a good lawyer to help is critical!