FDA’s PDURS Guidance: Questions Asked and (Not) Answered

With the exponential growth in digital health technology, drug and software developers alike increasingly have turned to mobile applications and other digital tools to improve patient experience. The result is prescription drug use-related software (“PDURS”)—things like diary digital apps in which patients input their symptoms and autoinjectors that can track and record the amount of drug dispensed. This pairing of drug use and software has long existed in a kind of regulatory limbo: the software may or may not be regulated as a medical device, and approved drug labeling may or may not incorporate digital tools. FDA recently published its long-promised draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (“PDURS Draft Guidance”), which explains FDA’s thinking regarding regulation of PDURS.

King & Spalding will host a one-hour roundtable webinar on November 15 to discuss the PDURS Draft Guidance and its implications. Topics for discussion will include:

•  FDA’s approach to PDURS output versus software function;

•  Regulation of PDURS output as labeling;

•  The PDURS framework and post-approval changes; and

•  Follow-on products and PDURS.