Featuring an expert panel of industry professionals and US Food and Drug Administration (FDA) regulators, this RAPS workshop will provide critical information on navigating the medical device submission process and creating compliance strategies for products for the US market.
Get step-by-step instructions to help you effectively communicate with FDA and explore case study examples that will provide unique insight into the perspectives of both FDA and industry.
Prepare to address needs and requirements that are outside the scope of existing guidance documents. Emphasis will be placed on audit inspections and premarket and postmarket compliance. Examine the ins and outs of device classification. Explore required timeframes and how the device review and documentation process differs according to device classification, and much more.
In addition to managing content throughout the lifecycle, every regulatory professional should know the standards, groundwork, expertise and technology required to produce an e-submission for FDA. As the Global Harmonization Task Force (GHTF) works to develop standards for the content of device submissions (STED), regulatory professionals need to work to become up-to-date on the current processes and technical requirements to efficiently tackle the next steps in e-submissions.