FDA Addresses Device Constituents in New Draft Guidance on Container Closure Systems By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Jennifer D. Newberger —

https://www.thefdalawblog.com/2026/08/fda-addresses-device-constituents-in-new-draft-guidance-on-container-closure-systems/?utm_source=rss&utm_medium=rss&utm_campaign=fda-addresses-device-constituents-in-new-draft-guidance-on-container-closure-systems FDA recently released a draft guidance titled Container Closure Systems for Human Drugs and Biological Products. The draft supersedes a 1999 guidance and its 2002 Q&A supplement—documents written before the prevalence of container closure systems (CCSs) like pre-filled syringes, metered dose inhalers, and autoinjectors blurred the line between container and device. For Combination Product manufacturers, the new draft now explicitly acknowledges that a CCS may also be a device constituent or part of a device constituent and mentions, although with no specificity, that some recommendations may also be applicable to stand-alone drug-delivery devices. However, the headline is that the draft guidance does not appear to introduce anything that has not already been covered in another guidance related to combination products.