FACE-Q Aesthetics is Qualified as a New MDDT

FACE-Q Aesthetics can be used by medical device companies to assist in the evaluation of devices used in aesthetic facial procedures

If your email program has trouble displaying this email, view as a webpage.   FACE-Q | Aesthetics Patient-Reported Outcome Instrument Is Qualified as a New Medical Device Development Tool The U.S. Food and Drug Administration (FDA) qualified a portion of the FACE-Q | Aesthetics patient-reported outcome (PRO) instrument, also known as a questionnaire, through the voluntary Medical Device Development Tools program. The FACE-Q | Aesthetics instrument consists of independently functioning scales and checklists. The MDDT-qualified FACE-Q | Aesthetics instrument: Can be used by medical device companies and sponsor-investigators to design feasibility, pivotal, and post-approval studies to support the effectiveness of a device. Should not be used as the sole primary effectiveness endpoint. Is comprised of the following 11-qualified scales that can be used independently to quantify aspects of a person's quality of life and satisfaction with facial aesthetic surgical or non-surgical procedures: Satisfaction with Cheeks Satisfaction with Facial Appearance Lines Between Eyebrows Appraisal of Lines: Nasolabial Folds Satisfaction with Lips Satisfaction with Skin Aging Appraisal Early Life Impact of Treatment Satisfaction with Outcome Psychological Function Social Function Read More Questions? For more information about the FDA's Medical Device Development Tool program or for questions, contact MDDT@fda.hhs.gov.

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