FDA 513g Guidance

Medical Device manufacturers often file a FDA 513g request to establish if the requirements apply to a product and whether the FDA 510k 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 FDA 513g.

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 FDA 513g Section of the Federal Food, Drug, and Cosmetic Act, through which anyone can acquire answers on how the FDA would categorize their product.

How to Submit FDA 513g Application?

Companies that manufacture medical devices must submit a written FDA 513g 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 513g 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.

FDA 513g Guidance:

1. Purpose: The FDA 513g process is designed to provide clarity and guidance to manufacturers regarding the regulatory requirements for their medical device. It allows manufacturers to proactively seek information from the FDA before proceeding with a formal submission or to clarify any uncertainties related to device classification, regulatory pathway, or applicable regulations.
2. Information Request: To initiate the FDA 513g process, manufacturers need to submit a written request to the FDA, providing a detailed description of their device and the specific questions or issues they want the FDA to address. The request should include relevant documentation, such as device specifications, intended use, and any available supporting data.
3. FDA Response: Upon receiving a 513(g) request, the FDA will review the information provided and provide a written response to the manufacturer. The response may include a determination of the device’s classification, applicable regulations, or guidance on the regulatory pathway to follow for market authorization. The FDA’s response helps manufacturers gain clarity and understanding of the regulatory requirements specific to their device.
4. Benefits: The 513g process offers several benefits to manufacturers. It allows them to obtain formal feedback from the FDA before investing significant resources in the development, testing, and regulatory submission of their device. It can help manufacturers make informed decisions about the appropriate regulatory pathway, prepare a comprehensive submission, and ensure compliance with the FDA’s regulations.
5. Limitations: It is important to note that the 513g process does not provide a formal approval or clearance for a device. It is an information request pathway, intended to provide guidance and clarification. The FDA’s response to a 513g request does not guarantee market authorization or exemption from regulatory requirements. Manufacturers still need to follow the appropriate regulatory pathway, such as the 510(k) clearance or Premarket Approval (PMA) process, to obtain formal FDA approval or clearance for their device.

Overall, FDA 513g provides a valuable mechanism for manufacturers to seek regulatory guidance and clarification from the FDA. It can help manufacturers navigate the complex regulatory landscape and make informed decisions about the development and regulatory submission of their medical devices.