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# FDA Should Develop Vision PRO Tool: AdvaMed
- URL: https://www.fdaweb.com/fda-should-develop-vision-pro-tool-advamed/
- Published: 2023-10-30T12:00:00.000Z
- Updated: 2026-09-14T14:14:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155674

The Advanced Medical Technology Association (AdvaMed) is urging FDA to proceed with stakeholder recommendations to develop a “central item bank or horizontal PRO \[patient-reported outcomes\]” tool for all vision disease states in clinical trials. AdvaMed’s [comments](https://downloads.regulations.gov/FDA-2023-N-3787-0007/attachment%5F1.pdf?ref=fdaweb.com) were submitted to the docket of a 9/29 FDA virtual public workshop entitled “Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires.”

“Given FDA’s push towards utilizing PROs as an input to regulatory decision-making, we believe such an approach could be beneficial to advancing innovation,” AdvaMed said. “Industry would be interested in leveraging such a tool in clinical datasets as part of marketing authorizations.”

AdvaMed supported workshop participants and their discussions on the benefits of gaining greater insights and information about patient experience with ophthalmic devices and procedures through the use of PROs. “PROs can help inform technological advances as well as regulatory decision-making,” the group said, adding that PRO instruments can also be challenging and resource-intensive (costly) to develop.

“From a company perspective, the development of PRO instruments continues to be a burdensome, costly and lengthy process which has the potential to limit innovation in the ophthalmic space,” AdvaMed told the agency. “The significant costs, the extensive development time which can be longer than the device development timeframe, and the uncertainty of whether the PRO will be accepted by FDA after sponsor investments of significant time and resources, meaningfully discourage interest in and investment in PRO instruments.” All of these hurdles point to having FDA lead the development of the PRO tools to eliminate some of the perceived burden and uncertainty, AdvaMed said.