The FDA is seeking public comments for a proposed framework that would allow the majority of apps and software released by pharmas that accompany a drug treatment to avoid lengthy premarket review submissions.According to a notice released last week, such software would be viewed as promotional labeling, and therefore only require submission to the FDAs Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB) at the time of initial dissemination.The notice offers some examples of branded prescription drug-use-related software (PDURS) that would fall under the category of promotional labeling or otherwise. These included: PDURS that provides patients with information about the drug that is also available within the FDA-required labeling, digital tools to track the condition related to the prescribed treatment, software that allows the patient to enter a drug regimen for reminders, and other outputs that would not qualify the software as a medical device or FDA-required labeling.The focus of this proposed framework is not on whether the software is a device, the agency wrote in the notice. While FDA anticipates that some PDURS will meet the definition of a device, other PDURS will not meet this definition. This proposed framework does not alter the regulatory framework for devices, but focuses on the output of software disseminated by or on behalf of a drug sponsor for use with one or more of its prescription drug(s).

Source: Click here