MEDICAL DEVICE DEVELOPMENT TOOL (MDDT) INFO
The FDA MDDT program helps researchers get tools qualified for use in medical device research. Once a tool is qualified, it can be used in clinical trials for its specified context of use without sponsors having to prove again that it works for that purpose. Here is a summary of evidence and basis of qualification decision for FACE-Q Aesthetics.
LABEL CLAIMS
FACE-Q Aesthetics scales have been used as endpoints in FDA-approved product labels to evaluate patient satisfaction and quality of life following facial aesthetic procedures. Here are some examples label claims.
Setting the Bar in
Patient Reported
Outcome Measurement
Funding Provided By:
