This workshop will be held as scheduled. Should plans change, RAPS staff will contact attendees directly via email.
7–8 March 2013
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 examples that will provide unique insight into the perspectives of both FDA and industry.
Prepare to address needs and requirements 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.
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 on their risks and benefits and intended use. Each successive 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 relating to both quality and risk
- Coordinate import and export activities effectively
Who Should Attend
This program will benefit early to mid-level professionals working on US submissions.
Learning Levels: Basic, Intermediate