This 3-hr virtual seminar will explain in detail the components and format of a 510(k) Premarket Notification and cover strategies for preparing and submitting a successful 510(k) submission.
Why Should You Attend:
The 510(k) submission is made to the FDA to demonstrate that a subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).
FDA generally requires 510(k) notification for Class II devices. The 510(k) process is relatively quick and relatively inexpensive (FDA aims for a 3 month review process). However, in reality, the review process can take considerably longer, from 6 months to one year in some cases.
Areas Covered in the Seminar:
- FDA regulations applicable to a 510(k) submission.
- Overview of the 510(k) program and recent changes in the 510(k) program.
- Identification of the 510(k) regulatory requirements.
- Discussion of the 510(k) submission requirements for medical devices and in vitro diagnostic devices.
- How to identify and select an appropriate Predicate Device.
- List of applicable FDA guidance documents and reference standards.
- Systematic methods to increase 510(k) submission quality.
- Formatting a 510(k) for submission; 510(k) contents for medical devices and in vitro diagnostic devices; and strategies for preparing successful 510(k) notification submissions.
- Responding a CDRH Responses to a pending 510(k).
- Instructor’s recommendations for success.
Who Will Benefit:
- Regulatory Affairs Professionals
- Product Managers
- Research Analysts
- Medical Device Start-ups
- Foreign Manufacturers
Added by complianceonlinecom on November 7, 2012