This is the audio-only version of RQM+ Live! #37, originally recorded June 17, 2021.

The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need them.

We often get the questions, "Where do I start?" and "How do I know if my device qualifies?" In this Live! show, our panel of regulatory experts (including former FDA CDRH representatives) will discuss the following and more:

If you'd like to learn more about the options and challenges associated with getting innovative devices to the US market, please join us and bring your tough questions for our panel to answer live!

The panel will include:

-

About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.