Join MassMEDIC, along with RAPs Boston Chapter and ASQ Medical Device Discussion Group New England Division, for this half day virtual conference reviewing FDA priorities over the last year.
9:00am: Welcome Remarks
9:15am: Morning Keynote: Anindita Saha, Assistant Director, Digital Health Center of Excellence, FDA with by Q&A with Veeva MedTech.
10:00am: Panel Discussion with RQM+
"What’s happened in 2021?" In 2021, FDA has been focused on both streamlining existing process and providing more tools especially for innovative devices. Even with the lingering covid impact, FDA has launched a new program for innovative devices (STeP), several process improvement tools (eSTAR, Submission Tracker), and multiple new cross-cutting Guidance Documents (e.g. Software, MRI, Several De Novo Guidances). With so many new updates, which updates should companies be aware of and how should they make the best use of them?
10:30am: FDA 510(k) Clearance Process: Sean Burke and Rick Ball from Duane Morris LLP discuss the basics of 510(k) clearance, marketing, promotion and its impact on product liability claims.Rick and Sean will discuss the 510(k) process and how a growing number of courts are consistently banning the introduction of evidence at trial under the argument that 510k clearance carries little weight.
11:00am: Uncovering and Maximizing the Value of FDA Inspections with Colin Tack, Lieutenant, U.S. Public Health Service, Medical Device Investigator. In this session, an FDA investigator will uncover the value that FDA inspections present to industry stakeholders and patients while providing tips to make the inspection a positive process for your organization. The session will also cover how to use available data generated from inspections of industry peers to improve your organization.
11:30am: Cures 2.0 Update with Todd Gillenwater, Sr Director, Government Affairs, Medtronic and Anthony DeMaio, Senior Director, ML Strategies.