US FDA Announces New Framework for Prescription Drug-Use-Related Software
Summary
According to FDA, if the output is consistent with FDA-required labeling and does not lead to an increase in potential for harm to health for the user, prior advisory comment is not needed.The proposal provides several examples of software applications that may include output that fits into this category, such as apps with reminder and tracking functionality that generally fall within the policy of enforcement discretion articulated in the guidance document, Mobile Medical Applications, when not distributed by or on behalf of a drug sponsor for use with a prescription drug.3.Certain output to be regulated as promotional labeling would be subject to the above dissemination requirements in addition to FDA’s recommendation that the sponsor seek advisory review in advance of the submission.These applications seem to fall within CDRH’s proposed policy for Patient Decision Support Software, under which certain low-risk software tools intended for patients or caregivers who are not healthcare professionals would not be actively regulated as devices, when not distributed by or on behalf of a drug sponsor for use with a prescription drug.The proposal seeks to “provide drug sponsors the flexibility to innovate and to disseminate prescription drug-use related software without prior FDA approval.” Because the software that produces the output remains subject to regulation as a device component of a combination product, however, the practical effect of excluding output from prior FDA approval is unclear.