QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo

Medical device manufacturers and other industry stakeholders are waiting for the draft harmonized Quality System Regulation from the US Food and Drug Administration with breath that is bated. The agency has been working on the QSR redo – which better aligns the decades-old rule with international quality systems standard ISO 13485:2016 – for more than three years now.

The draft QSR, which will become the bedrock rule for manufacturing safe and effective devices in the US when finalized, is expected to come this year. (Also see "After QSR Delays, ‘It’s Full-Steam Ahead With That Proposed Regulation,’ FDA’s Shuren Vows" - Medtech Insight, 6 May, 2021.)

In the meantime, Medtech Insight rounded up a handful of top medtech experts to answer six questions about the upcoming draft regulation, including:

  • Vincent Cafiso, senior director of regulatory compliance & global audit at device maker Smith & Nephew;
  • Kwame Ulmer, principal consultant at Ulmer Ventures and cofounder of MedTech Color;
  • Kim Trautman, longtime medical device, IVD and combination product expert, and an ex-FDA official who was the lead author of the current Quality System Regulation (21 CFR Part 820) in the 1990s;
  • Josh Levin, director of quality assurance and regulatory affairs at device company ASELL LLC; and
  • Steve Niedelman, lead quality systems and compliance consultant at the law firm King & Spalding, and a 34-year veteran of the FDA.

The questions and answers are below. Trautman and Niedelman were interviewed by Medtech Insight, while Cafiso, Ulmer and Levin provided written responses....