HealthTech Activator - Engaging with the US FDA: Medical Device Regulatory Webinar

We are excited to announce a new upcoming HealthTech Activator (HTA) Medical Device Regulatory webinar - Engaging with the US Food and Drug Administration (FDA). This webinar will provide participants with an overview of ins and outs of FDA engagement for medical device companies and include a discussion of significant FDA initiatives.

Tune in to learn about:

• The FDA’s mission and jurisdiction, and how it regulates medical devices through the Center for Devices and Radiological Health (CDRH)
• What effective FDA engagement means, and why it matters
• The ‘How to’ of effective FDA engagement, the role of innovation, and what to do if engagement goes wrong
• An overview of significant FDA future initiatives, including the role of real-world evidence and regulation of digital devices

This webinar will be presented by Steve Silverman, President of the Silverman Group - a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Steve has previously held roles including VP Technology and Regulatory Affairs at AdvaMed, Senior Expert at McKinsey & Co., and Director of the FDA’s CDRH Office of Compliance. 

Event details:

• 15 June 2023, 9:00am-10:30am including 20 minutes Q&A
• Cost: Free
• Attendance will be limited to enable attendees to engage in the Q&A session 
• Hosted on Zoom, questions can be submitted via the Zoom chat 
• You can also pre-submit a question via the registration for this event 
• The webinar will be recorded and available on the HTA website webinars page post-event, but the recording will not include the Q&A  
• All who attend the webinar will also receive a copy of the slides  

Attendance is limited to two attendees per NZ-based, HTA-subscribed organisation (subscribe here). Please confirm your place no later than 14 June 2023.

Steve Silverman

President, The Silverman Group

Steve Silverman is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Steve also serves as an expert witness on medical product regulatory matters.

Before this, Steve worked as Vice President, Technology and Regulatory Affairs, with AdvaMed, the leading medical-device trade association. Steve focused there on product quality and compliance, pre-market approval, and device advertising and promotion. Adding to this, Steve was a Senior Expert with McKinsey & Co., where he counselled medical device and other clients on regulatory strategies, product compliance and quality, and stakeholder communication.

Steve’s professional experience includes nearly two decades in federal service, with extensive time in senior FDA roles. At the FDA, Steve directed the CDRH Office of Compliance, where he led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganisation. Steve’s FDA roles include Assistant Director, CDER Office of Compliance, where he oversaw implementation of drug regulations, policy, and public communications about prescription and over the counter drugs. Steve began his FDA work as an Associate Chief Counsel, where he led enforcement actions against drug and medical device companies. Steve’s past work includes positions with the US Department of Justice and the Federal Trade Commission.