Before going too far, let’s take a moment to recognize a pretty grand achievement by the collective DevOps community. For years, the US Food and Drug Administration maintained a very slow, cumbersome, and costly approval process for medical apps. A bad medical app puts lives at risk. Previously, if a medical app requiring FDA approval failed its review, it could take 7 to 9 months to be reviewed again.
Tasked with responding to the broader healthcare pains in the United States, the FDA started to modernize. This led to the 2019 Software Pre-Cert Pilot Program and the Digital Health Innovation ActionPlan. Here, the FDA is aligning its processes around continuous product development. The focus shifts some from the product to how the company developing it handles the entire product life cycle. Now, they may provisionally approve an app with a bug knowing the company will rapidly fix it.