In April, the Food and Drug Administration (FDA) released a public working model of the Software Precertification Program. This program is envisioned as a voluntary pathway which embodies a regulatory model more tailored than the current regulatory paradigm which will assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.
FDA Commissioner Scott Gottlieb when introducing this new working model, noted that this is the “first, high level draft,” in which the FDA introduces some new details about how the pre-certification program might work in practice. FDA is looking to have different levels of pre-certification, with the best developers getting streamlined or waived review for relatively more consequential software updates or introductions.
In this “first, high level draft,” the FDA asks a number of questions for which they are seeking stakeholders, like HIMSS to comment by May 31 to help shape the next steps of the precertification program going forward