U.S. FDA Temporarily Eases Enforcement Policies for Certain Digital Health Devices

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak in the U.S., the Food and Drug Administration (FDA) has issued a Guidance document that signals the agency’s intent to temporarily ease enforcement for certain types of devices.

Issued on April 14th, the Guidance provides a policy to help expedite the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while also helping to reduce user and healthcare provider contact and exposure.

Specifically, the Guidance states that:

“for the duration of the COVID-19 public health emergency, FDA does not intent to object to the distribution and use of computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders…without compliance with the following regulatory requirements, as applicable, where such devices do not create an undue risk.”

The Guidance notes that the FDA’s decision to ease its enforcement policies for devices that have not received pre-market approval does not apply to previously 510(k)-cleared devices. Further, the easing of enforcement polices remains in effect only for the duration of the COVID-19 public health emergency.

Guidance documents issued by the FDA and other federal agencies are intended solely to provide interested parties with information on the current views of the agency with regard to a specific issue, and do not have the force of law.

Read the FDA’s Guidance on digital health devices.

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