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FDA Qualifies Facial PRO As New Medical Device Development Tool

 
• By Brian Bossetta

The US agency has qualified the FACE-Q | Aesthetics patient-reported outcome instrument through its MDDT program.

FDA BUILDING
• Source: Alamy

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.

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