Course offering number:1005-711
Course ID:
2414
Be Prepared: CDRH Changes Are On the Way
In Conjunction with Medical Device Summit
Pre-recorded Course
FREE On-Demand Webinar
Who Should Attend
This course is designed for professionals primarily in the medical device industry. However, interested parties in the pharmaceutical and
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
Want to keep your medical device company ahead of the curve? Concerned about rumors of major changes in the FDA's Center for Devices
and Radiological Health (CDRH)? Need to know the details of dramatic changes in FDA device approval and regulation policy? Join us for an
advance look at the soon to be announced major changes in CDRH. You'll hear the latest inside information about organizational changes, shifts
in 510(k) submission requirements; redefinition of "predicate devices" and FDA plans for reviewing grandfathered devices.
If you're designing, manufacturing, selling, or using a regulated medical device this program is an advanced look at the information you need to have.
The program includes:
• Major CDRH corruption charges
• Changes in the use of the 510(k) and 513 designations
• New requirements for providing device safety and efficacy
• Changes in "predicate device" interpretations
• Requirements for "grandfathered" devices
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.