Latest From Elizabeth Orr
A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.
The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.
To determine how non-device functions are regulated, the US agency looks at what kind of effect they have on the device itself.
US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.