Course Details
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. This is a pre-recorded webinar. 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, and • how FDA’s medical device premarket notification (510k) process works. This course will benefit: • medical device manufacturers, including dental custom implant abutments
