5–7 March 2012
RAPS Training Facility
Due to popularity, maximum capacity for in-person attendance for this event has been reached. Virtual attendance is still open. If you have questions, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or email@example.com.
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 be up to date on the current processes and technical requirements to efficiently tackle the next steps in e-submissions.
About the FDA Review Process
FDA has three statutory mechanisms for device review prior to human use or marketing clearance/approval: Investigational Device Exemption (IDE) (21 CFR 812), Premarket Notification (510(k)) (21 CFR 807.81) and Premarket Approval Application (PMA) (21 CFR 814). Medical devices are assigned one of three (I, II or III) classifications based upon their risks and benefits and intended use. Each class imposes an increased level of regulatory control with Class I (General Controls) having the lowest level of regulatory control and Class III the highest (General Controls, Special Controls and Premarket Approval). The device review process differs according to the device classification, as does the type of documentation required. Each submission type has different timeframes for FDA review and response.
At the conclusion of this workshop, participants should be able to:
- Integrate device classification, strategy and regulatory intelligence
- Strategically plan presubmission meetings and communications with FDA for 510(k)s, IDEs and PMAs
- Understand premarket notification background, substantial equivalence and techniques for identifying predicates for 510(k)s
- Articulate best practices and useful tips for 510(k)s, IDEs and PMAs
- Apply insights on clinical design control, inspections and advertising and labeling
- Effectively manage postmarket surveillance and event reporting
- Proactively perform compliance activities
- Identify fundamental strategies for preparing to submit e-submissions
- Explain the technical requirements of an eSubmitter submission
- Demonstrate best practices in the use of MS Word and Adobe Acrobat in preparing content for submissions
- Facilitate the transition to e-submissions within their organizations
Who Should Attend
This program will benefit early to mid-level professionals working on US submissions for their organizations.
Learning Levels: Basic, Intermediate