Just when you thought it was legal to market your medical device, you find out that your distributor is asking for your establishment registration in the state they are located in. What is going on? Targeting the activities of companies which manufacture or distribute prescription drugs, some states also impose regulations on manufacturers and / or distributors of prescription or "legend" devices. If your device bears the following "legend:" "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician" then your company may be required to register at the state level. Nu Device will gladly check current requirements for states that you plan to do business in and prepare your registration submission. We are tracking requirements state-by-state; watch this page for details. Please see the report Licensure Standards for Medical-Surgical Products Distributors from the Health Industry Distributors Association for guidance.

If you are marketing your device at the state level, you also want to be aware of possible disclosure requirements. This affects financial dealings with healthcare providers, ie possible payments to physicians.

210 Farmers Top, Murphy NC 28906

Tel: (603) 477-7685 Fax: (603) 869-7669

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August, 2015. All rights reserved.