Live Webinar: Is Your Product a Medical Device? FDA Compliance Requirements
Instructor: Shelly Garg
April 21, 2022 | 1:00 pm – 2:30 pm (EDT)
Reserve Your Seat
Webinar Overview:
Sunglasses, band-aids, cosmetic facial toning devices, decorative contact lenses – FDA regulated medical devices or not?
For manufacturers of medical devices and related products, U.S. export controls are not the only set of regulations that apply. The U.S. FDA regulates all kinds of products, including medical devices. Some products seem to more readily and more squarely fit into the traditional “device” category, while other products can surprisingly be regulated by the U.S. as medical devices. Ensuring that your Company meets legal marketing requirements is critical to being able to successfully market such devices, reduce the chance for regulatory enforcement, avoid import delays, maintain consumer confidence, and preserve your bottom line.
This webinar will cover the following:
- Brief History of FDA Regulation of Medical Devices
- Methods for Device Classification
- How to assess whether a product is a medical device
- FDA Device Marketing and Regulatory Requirements
- Enforcement Activity
- Question & Answer
Click here to learn more and register.
This webinar will include PowerPoint slides and live video and commentary from Shelly Garg. Each registrant, even if unable to attend live, will have access to the presentation, certificate of completion, speaker contact information for follow-up questions, and access to the webinar recording the next business day after the webinar airs. Webinar participants are invited to submit questions during the webinar and the final 30 minutes will be allotted to answering attendee questions.