513(g) Requests for Classification
Under Section 513(g) of the Food, Drug, & Cosmetic Act (the Act), a person can request a classification decision from the FDA for a new or modified device for which there is no clear classification already available. The FDA’s written guidance, as a result of a 513(g) submission, can be valuable in making decisions about the appropriate regulatory strategy for product commercialization. This guidance is also sometimes useful in discussions with potential distributors, marketing partners, or investors. In addition, all of the elements of the 513(g) may be incorporated into the 510(k) Premarket Notification should the FDA classify the product as a Class II device.
Contact MDCI today for help with your 513g request for classification.
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Device Regulatory Guidance
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