Course offering number:1007-708
Course ID:
2405
CDRH: Get Ready for Changes!
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is designed for professionals primarily in the medical device industry. However, interested parties in the pharmaceutical,
biotechnology and biologics fields will also benefit from this training. It will be especially beneficial to:
• Regulatory/QA Managers
• Directors and VPs
• Planning Executives
Description
According to the FDA "Medical devices distributed in the United Sates are subject to General Controls, pre-marketing and post marketing
regulatory controls." New FDA guidelines, regulations and interpretations emerge constantly from the agency that controls almost a third of the
US economy. Keeping up with these changes is a constant challenge. This 90-minute accredited online training will address the CDRH
changes with focus on the effects of this revolution. Special attention will be given to the resulting streamlined procedures and the future plans
of the organization.
Module 1: Effects of the "revolt":
• Behind the scenes
• Predicate devices
• Grandfathered devices
Module 2: New review criteria:
• 510k and PMA
• Establishing safety
• Establishing efficacy
Module 3: Streamlined procedure:
• How to proceed
• 505(b)2 equivalent
• More changes coming
Question and Answer Session
About Medical Device Summit
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing, digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.
MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix of journalistic-style articles, technical articles, blogs, white papers, press releases and news.
For more information visit their website at www.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.