A Preview of MDUFA VI: Changes and Highlights, Part 2

MDUFA VI shifts the regulatory focus from further reducing review times—which have reached a practical limit—toward improving the quality and specificity of FDA feedback. Major deficiency letters for Class III PMAs and additional information requests often lack actionable detail, a trend exacerbated by high turnover and the hiring of inexperienced reviewers at the agency. Introducing a $2,000 pre-submission fee encourages better sponsor preparation, while expanding third-party review programs or adopting independent, non-governmental evaluation models could alleviate FDA resource constraints. Ultimately, meeting regulatory requirements represents only a baseline standard for safety; manufacturers must prioritize internal quality benchmarks that ensure device performance beyond mere compliance. Mike Drues, President of Vascular Sciences, provides these insights, emphasizing that while headcount increases are measurable, they do not guarantee the technical expertise necessary for effective regulatory oversight.