This draft guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder and used to support marketing submissions.
The updates align with the actions outlined in CDRH’s Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities.
The FDA updated the list of UV wand products that may present a potential risk of injury. The FDA recommendations have not changed.
The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023.
Existing emergency use authorizations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the Federal Food, Drug, and Cosmetic Act are in effect and when the criteria for issuance of an EUA are met.
