FDA offers own version of "Turbo Tax" to help on 510(k) compliance
This article was originally published in Clinica
Executive Summary
An FDA task force is at work on a software program designed to help diagnostic companies fill out their 510(k) notifications. Don St Pierre, deputy director of the Office of In Vitro Diagnostic Evaluation and Safety (OIVD), predicted that the initiative could cut review times in half. "That's going to be a drastic change," he told the annual meeting of the Regulatory Affairs Professionals Society last week.