FDA published a revised draft guidance on October 30 titled Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products. It replaces the June 2024 draft, which was called Essential Drug Delivery Outputs. Comments close January 28, 2027, under docket FDA-2024-D-2560.
The guidance applies to stand-alone devices and to combination products with a device constituent part that delivers a drug or biological product. It recommends what drug delivery performance information to include in investigational applications, marketing applications and submissions for post-market changes. FDA says the aim is more consistent performance information across programs.
For anyone building an autoinjector, a pen, a pump or an inhaler, the operative question is which measurements FDA counts as essential, because that list sets the verification protocol and decides which design changes trigger a new submission. Read it before the next design freeze rather than after, and file a comment if the list does not match what your test bench can actually measure.