Section 513(g) of the FDA
One of the difficulties that medical device manufacturers encounter is deciding how to proceed with the development of a device without identifying the risk class of the device. To overcome this, the Food and Drug Administration provides a method in Section 513(g) of the Federal Food, Drug, and Cosmetic Act, through which anyone can acquire answers on how the FDA would categorize their product
Device manufacturers often file a 513(g) request to establish if the requirements apply to a product and whether the 510(k) regulations apply to the device. If they want to change a device, they may submit the request to determine whether they need to file a 510(k). Determining the simplest way to get a device approved may also be a cause for a device manufacturer to submit a 513. (g).
How to Submit an application for 513(g)
Companies that manufacture medical devices must submit a written 513(g) application to the relevant agency and designate it as such. A cover letter, a description of the item, information on its intended usage, any suggested labelling, and promotional materials for the device should all be included in the application.
The request should be identified as a 513(g) request for information in the cover letter. The 513(g) requester’s signature, the date of the request, the name of the device, details identifying the device’s class, the requester’s name and contact information, and the date should all be provided.
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