SafeLink: 3 Ways Your Product Offerings Can Trigger FDA's Attention
Is the information on your website triggering FDA’s attention to your business? Branding, using proprietary names, and marketing custom devices affect how your business model is portrayed to FDA. From importation of devices to manufacture of devices that require FDA 510(k) clearance, learn what you could expect from FDA and the impact it could have on your business. For devices requiring a FDA 510(k) clearance, the presenters discuss how to get devices on the market and how to manage subsequent changes.
Take this course to learn more about:
• FDA regulated activities for medical devices
• How registration and listing errors can increase FDA scrutiny
• How public media marketing exposes a business activity to FDA
• How FDA’s medical device premarket notification (510k) process works
This course will benefit:
• Medical device manufacturers, including dental custom implant abutments.
This is a pre-recorded webinar. Please disregard any reference to NBC course approval numbers made in this webinar.
Requirements for Course Completion
Participants will view the one-hour video and complete a short quiz. Participants must correctly answer at least 80% of the quiz questions to receive credit. If a grade of at least 80% is not achieved, the quiz may be repeated two times.
Upon successful completion of this course, participants will receive one hour of documented Regulatory Standards through the National Board for Certification in Dental Laboratory Technology (NBC). Credit will automatically be submitted to NBC on your behalf.