At the start of the year, the FDA updated two guidance documents. Here is a brief overview of the key changes.
a) General Wellness: Policy for Low Risk Devices
In contrast to medical devices, the guidance defines general wellness products as products that meet the following two criteria:
- They are intended exclusively for general wellness purposes, and
- They present a low risk to the safety of users and other persons.
According to the FDA, this can also cover products that use non-invasive sensors (optical sensors, for example) to estimate, derive or output physiological parameters (such as blood pressure, oxygen saturation, blood glucose or heart rate variability).
This clarifies the FDA’s position on this product category. As recently as last autumn, the manufacturer of the WHOOP fitness band received a warning letter from the FDA over its feature for estimating blood pressure as a systolic and diastolic value. This, the FDA argued, qualified the band as a medical device, because blood pressure cannot be used without reference to a disease. The FDA is now making clear that non-invasive blood pressure readings can also be permissible without medical device status.
You can read the guidance here: General Wellness: Policy for Low Risk Devices | FDA
b) Clinical Decision Support Software guidance
The FDA does not classify clinical decision support software as a medical device if all of these conditions are met:
- The software is not intended to acquire, process or analyse medical images, signals/patterns from in vitro diagnostic devices or signal acquisition systems.
- It is intended to display, analyse or print medical information about a patient or other medical information,
- It supports healthcare professionals or gives them recommendations on prevention, diagnosis or treatment.
- It enables healthcare professionals to independently review the basis for the recommendations given by the software. It is not intended that they rely primarily on the software’s recommendations to make a clinical diagnosis or treatment decision.
The guidance on clinical decision support software has now been revised in the following respects, among others:
Recommendations without a second option: under “enforcement discretion”, the FDA now permits CDS tools that give only a single recommendation, provided the other criteria listed above are met. Previously, a list of options always had to be displayed for the software not to count as a medical device, which was often impractical and not clinically useful.
Support for clinical review: software that displays, analyses or prints medical information often remains exempt from FDA regulation, as long as healthcare professionals can review the recommendations independently. This relieves manufacturers of unnecessary regulation.
Focus on usability and transparency: the FDA now emphasises that clinically relevant information should be presented clearly and legibly. At the same time, it stresses that the recommendations issued by the software must be based on recognised, evidence-based sources.
You can find the published guidance here: Clinical Decision Support Software | FDA