Posted by Michael Wonder on 28 Jan 2018
Transparency and dermatologic device approval by the US Food and Drug Administration
24 January 2018 - What post-approval changes occur to Class III dermatologic devices approved by the US FDA via the pre-market approval pathway?
In this cross-sectional database study of 27 dermatologic devices, manufacturers are shown to increasingly modify devices via supplement pathways that require minimal supporting clinical data.
Post-approval changes to Class III dermatologic devices may result in inadequately studied modifications that could influence device effectiveness and safety.
