12–13 April 2010
RAPS Training Center - Rockville, MD
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Featuring an expert panel of industry professionals and FDA regulators, this RAPS workshop will provide critical information on navigating the process of medical device submission and creating compliance strategies for medical devices 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.
You will also learn how to address needs and requirements that are outside the scope of the guidance. Emphasis will be placed on audit inspections and premarket and postmarket compliance. Additionally, you will learn the ins and outs of device classification, explore required time frames and how the device review and documentation process differs according to the 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) classification 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 time frames for FDA review and response.
Program topics
- Device classification, strategy and research/regulatory intelligence
- Presubmission meetings and communications with FDA for 510(k)s, IDEs and PMAs
- Premarket notification background, substantial equivalence and techniques for identifying predicates for 510(k)s
- Best practices and useful tips for 510(k)s, IDEs and PMAs
- Insights on clinical design control, inspections and advertising and labeling
- Post-market surveillance and event reporting
- Compliance and inspections
Who Should Attend
This program will benefit early to mid-level professionals working on US submissions for their organization.
Professional Levels: I, II