The US Food and Drug Administration has qualified a portion of the FACE-Q | Aesthetics patient-reported outcome (PRO) instrument, which is composed of a set of 40 independently functioning scales that measure three domain areas – facial appearance, health-related quality of life and adverse effects of treatment after facial plastic surgery – as a new Medical Device Development Tool (MDDT).
The FDA qualified 11 of the FACE-Q scales as an MDDT.