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FDA Regulation of Medical Devices
Some products are readily recognizable as medical devices regulated by the Food and Drug Administration, but the distinction is not always so clear with items like sunglasses, bandages, dental night guards, condoms and decorative contact lenses. Understanding whether your product is a regulated medical device and complying with the associated 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.
- history of FDA regulation of medical devices
- how medical devices are classified
- which products are medical devices
- device marketing requirements
- enforcement activity
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