Are medical devices subject to product registration regulations?
No. Medical devices are not registered by the Food and Drug Unit under product registration regulations. If you are marketing a medical device either intrastate or interstate, it is in your best interest to check with FDA regarding whether the device may require premarket approval (see here). Also, unless you market your products exclusively and directly to patients, you will likely be required to obtain a license with the Louisiana State Board of Wholesale Drug Distributors.
