FDA Issues Guidance Documents and Action Plan Aimed at Easing Burdens on Digital Health Manufacturers

In the first week of February, the US Food and Drug Administration (FDA) released two sets of guidance documents (one draft and the other final), aimed at easing administrative burdens on medical device and digital health manufacturers, and facilitating growth while maintaining safety.

The first guidance finalized in February discusses in depth the FDA’s “Least Burdensome Provisions”, which is the concept that they will require the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.  This concept, they explain in the guidance, applies to all products that meet the statutory definition of a device.  One of the examples provided to the FDA’s Least Burdensome Principle in the guidance is the FDA’s approach towards mobile medical applications that pose a lower risk to the public.  In the previously issued guidance, the FDA noted that even though a mobile medical application may meet the definition of a medical device under their jurisdiction, they intend to use enforcement discretion to focus on medical devices whose functionality may be of higher risk.  To learn more about the FDA’s Least Burdensome Provisions, see the full guidance, and to learn more about FDA’s enforcement discretion guidance regarding low risk medical devices, see CCHP’s factsheet on the guidance.

The second draft guidance document would allow manufacturers of combination products (products that combine two or more different types of products that the FDA regulates, e.g. drug, device, biologics) to only submit one application for the combination product rather than multiple applications which can be highly burdensome.  An example of a possible mobile health combination product are pills that send a signal to a mobile device once they are ingested, alerting a healthcare provider that it has been consumed.  Under this guidance, the manufacturer would only need to submit one application to the FDA for the product rather than two for the medication and device elements of the product.  To learn more about the FDA’s current thinking on the criteria necessary for a single application, see the full guidance document.  Comments on the draft guidance are currently being accepted for a period of 90 days after publication in the Federal Register.

It is important to note that guidance is meant to provide clarity and predictability, and does not create or confer rights nor does it bind the FDA or the public to the policy.  It merely provides the FDA’s current thinking on the topic and should be looked upon as recommendations.

These guidance documents are also consistent with the goals of the FDA’s Digital Health Innovation Action Plan, which lays out the FDA’s Center for Devices and Radiological Health (CDRH)’s vision for fostering digital health moving forward.  Key elements of the plan include:

  • Issuing guidance to provide clarity on the medical software provisions of the 21st Century Cures legislation;
  • Launching an innovative pilot precertification program to work with our customers to develop a new approach to digital health technology oversight (FDA Pre-Cert for Software); and
  • Building FDA’s bench strength and expertise in CDRH’s digital health unit.

To learn more about the action plan, see the full report.