The United States Food and Drug Administration (FDA) has 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/dental 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
To read the FDA announcement and summary of its approval of the FACE-Q | Aesthetics PRO instrument, use the link below.
https://www.fda.gov/media/157956/download?utm_medium=email&utm_source=govdelivery