FDA qualification of a new Medical Device Development Tool

U.S. Food and Drug Administration sent this bulletin at 05/16/2024 11:09 AM EDT

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U.S. Food and Drug Administration, Center for Devices and Radiological Health

FDA Qualifies Assesment of IntraOcular Lens Implant Symptoms (AIOLIS) Instrument as a New MDDT

The FDA is announcing qualification of a patient-reported outcome (PRO) instrument through the Medical Device Development Tools (MDDT) program, to assess frequency and bother of ocular symptoms in certain patients after receiving bilateral intraocular lens implants.

The qualified AIOLIS instrument:

Can help quantify and provide patients and clinicians with information regarding visual symptoms.
Assesses symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses.

Qualified Medical Device Development Tools

Questions?

If you have questions about CDRH’s qualification of Medical Device Development Tools, email the MDDT program at mddt@fda.hhs.gov.

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