The Regulatory Affairs Professionals Society (RAPS) continues its support of medical device professionals in Europe with the launch of a workshop focused on 510(k) premarket submissions to the US Food and Drug Administration (FDA).
The two-day interactive workshop, which will take place in Dublin, 24-25 April, will place attendees face-to-face with the former director of FDA’s Center for Devices and Radiological Health and two other former high-level FDA officials and industry-leading experts on 510(k). These three experts will outline the regulations and dissect every aspect of the submission process to ensure compliance.
The event, called The Basics of 510(k) and Working with FDA, is part of a series of training workshops on key regulatory topics and the latest developments, also including the new Medical Device Regulation (MDR).
“This 510(k) workshop is a unique opportunity for European regulatory professionals to learn directly from senior former US FDA leaders who helped shape the 510(k) process,” said RAPS Executive Director Paul Brooks. “The medical device sector is global, and the US is one of the most prominent markets. Having a thorough understanding of the US 510(k) process allows regulatory professionals to develop effective and efficient strategies. This workshop helps meet the European regulatory community’s need for the latest information on best submission practices to achieve US clearances and support market success.”
The experts who will share their experience, tips and guidance to developing, preparing and submitting a 510(k) application to FDA are:
Heather Rosecrans, former director, 510(k) staff, CDRH, FDA
Dan Schultz, former director, CDRH, FDA
Donna-Bea Tillman, former director, Office of Device Evaluation, CDRH, FDA
Attendees will also gain a thorough understanding of the regulatory framework behind FDA classification of medical devices and how to engage and work closer with the agency during the submission process.
Brooks continued: “Our European members are extremely engaged and committed to the regulatory profession and we must endeavour to provide them with the highest level of support to ensure they stay at the forefront of their regulatory profession responsibilities.”
RAPS has seen its European member base increase by more than 36 percent to over 2,000 members across 35 countries. RAPS members work in many regulatory roles in the life sciences sectors in Europe, ensuring compliance with global regulations, driving regulatory excellence and advancing public health.