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RAPS Boston Chapter, MassMEDIC, & ASQ: Mid-Year FDA Update 2021

RAC Credits
Tuesday, 20 April 2021 (12:00 PM) - Tuesday, 20 April 2021 (4:00 PM) Eastern Time (US & Canada)

Member: FREE
Nonmember: FREE


Mid-Year FDA Update 2021: Priorities and Programs for the year ahead. MassMEDIC, along with ASQ – Medical Device Division New England Discussion Group & RAPS Boston Chapter, will be holding a half day virtual conference on April 20, 2021 to highlight the priorities and programs the FDA will be implementing in 2021.

We’re pleased to announce that key members of FDA leadership, including Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, will speak at the program.

In addition, we’ll hear from Trang Cox, Supervisory Consumer Safety Officer, will give an update on the agencies plan to re-engage in on-site inspections, as well asDA overview of their remote regulatory program.

Program Agenda:

12:00pm: Welcome Remarks
12:15pm: Lunch Keynote: Jeff Shuren, Director of the Center for Devices and Radiological Health details CDRH's 2021 priorities, followed by Q&A with Veeva MedTech's Seth Goldenberg.
1:15pm: Panel Discussion: FDA Submissions in 2021: How’s it going? With a focus on FDA regulatory submissions, this panel discussion will provide context for what occurred in 2020 and early 2021, and provide forward-looking guidance and expectations for the remainder of the year. Will the rest of 2021 be smooth sailing or is there turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives and regulatory leaders from multi-national medical device manufacturers, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timeline
2:00pm: Hot Topic: FDA Evidence In A Products Liability Matter—Lessons Learned And Practices For Mitigating Risks
2:15pm: Panel Discussion: Digital Health and the FDA
3:00pm: Hot Topic: Congressional Update
3:15pm: Closing Keynote: FDA Medical Device Remote Regulatory Assessment (RRA)- Learn about the RRA process and what to expect : In our efforts to maintain surveillance activities amidst the COVID-19 pandemic, OMDRHO developed and launched a process for remote regulatory assistance (RRA). RRA is a meaningful review of information voluntarily provided by a regulated establishment to determine compliance with regulations remotely. This process is designed to allow curtail and interactive engagement between FDA Investigators and firm personnel. Presented by Trang Cox, Supervisory Consumer Safety Officer.

Registration will be facilitated by MassMedic.  If you have questions or concerns, please contact MassMedic at 617-358-9780 or