A Streamlined Approach to Protecting the Public from Hazardous Laser Products

Executive Summary

It’s important that FDA review EPRC product reports in a timely manner to identify unsafe products, and act quickly if problems are found. The number of new products being reported to the FDA is increasing (> 3,000/yr), as well as the time required to review these reports. During the review process, companies continue to sell/distribute their products. Products that fail to meet FDA safety standards increase the risk of injuries. Delays in FDA enforcement results in a greater financial burden for companies who are required to make corrective actions or recall products. To reduce review time, and improve inter-reviewer consistency, we propose a smart Work Instruction (sWI) with built in letter generator for reviewing product reports and generating a review letters. The sWI will use a risk-based approach to optimize the report review process.

Team Members

William Calhoun (team lead), FDA
Ting Song, FDA
Corinne Tylka, FDA

Milestones

October 2018: Project selected into the HHS Ignite Accelerator
March 2019: Time in Accelerator Began
June 2019: Time in Accelerator Ended