FDA Action-Item List Shows Plans To Revamp De Novo, Combo Product, QSR Regs, And More

Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul.

Regulation written on multiple road sign

Current device priorities at the US Food and Drug Administration include updating its Quality System Regulation, as well as rules around de novo applications and combination product regulation, the spring 2020 Agency Rule List from the Department of Health and Human Services reveals.

The Agency Rule List is a regularly updated compendium of executive-branch actions planned for the near future. It includes proposed regulations, deregulatory actions, and planned tweaks to existing regulations.

More from Regulation

More from Policy & Regulation