FACE-Q Aesthetics is Qualified as a New MDDT

U.S. Food and Drug Administration sent this bulletin at 04/26/2022 03:14 PM EDT

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FDA - Center for Devices and Radiological Health

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Medical Device Development Tools Program

 

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

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Questions?

For more information about the FDA’s Medical Device Development Tool program or for questions, contact MDDT@fda.hhs.gov.