One of the hardest parts of developing a new device is determining exactly how to proceed with regulatory pathway, especially in the case of devices where initial assessments indicate multiple potential classes or uncertainty around clearly-defined class. The FDA can help manufacturers through this process. Section 513(g) of the Federal Food, Drug, and Cosmetic Act outlines a procedure for device manufacturers to work with the FDA to determine how their prospective device would be classified. This is an essential first step in determining a device’s development and approval process.
Section 513(g)
Section 513(g) of the Federal Food, Drug, and Cosmetics act allows device manufacturers to submit a written request to the secretary of the FDA regarding how a device would be classified, and to receive a written reply including how the device would be classified, which regulations would apply to it, and what the approval process for it would look like, within 60 days. This is somewhat more complex than writing a personal letter to the secretary of the FDA, though. The 513(g) process is much more formalized and codified than the letter of the law indicates.
The key reason for submitting a 513(g) request is for manufacturers to learn which regulations will apply to their device and especially whether it will be subject to 510(k) regulations. The majority of medical devices are covered by 510(k), which provides a clear regulatory pathway for a device to be developed, tested, documented, manufactured, and serviced. Some devices will not be subject to 510(k), especially in cases where manufacturers are simply making a small change to an already-approved device. This can save manufacturers weeks or months of regulatory back-and-forth and documentation submissions, and even in cases where a 510(k) is required, manufacturers can learn about the least-cumbersome way of getting their devices approved.
How to Submit a 513(g) Application
A 513(g) application can be submitted online. For devices regulated by CDRH, directions for submitting online can be found here, while manufacturers of devices regulated by CBER should go here. Applications should include a cover letter, a description of the device, a description of the indicated use of the device, as well as proposed labeling and marketing materials for the device.
The cover letter should clearly state that the document is a 513(g) request and include the date of the request, the name of the device, and the requester’s name, contact information, and signature. Cover letters are also essential parts of the process because they provide an opportunity for manufacturers to ask questions or even lay out arguments about potential regulatory categories for a proposed device. This can not only streamline the reply process, but also predispose the FDA to view a device in a favorable way for the manufacturer.
Submitting a 513(g) application will also require the payment of user fees. The FDA is legally required to collect these fees for any requests for information, and they won’t process a request until all fees are paid. This can include facility registration fees, so it’s a good idea to review your company’s accounts to make sure these fees are up to date before proceeding. Notably, these fees can be refunded if the submitted request does not qualify as a 513(g) request.
FDA Feedback: What They Will and Won’t Provide
The FDA will tell a 513(g) applicant:
Whether or not the described product qualifies as a medical device. If the product does not qualify as a medical device, it may fall under other forms of regulation, but this is generally an ideal outcome for manufacturers since medical devices are heavily regulated and have complex approval processes.
The type and class of medical device the product will be regulated as, and any application requirements that are specific to this class.
Whether premarket approval application (PMA) or a 510(k) application are required. Some devices require one of these, some both, and some neither.
Special guidance and requirements for the particular device class. Some devices have more stringent sanitation, handling, or warning label requirements, especially those that include radioactive components or potentially-lethal drug doses.
The FDA will not tell a 513(g) applicant:
Whether a device is substantially equivalent. This means manufacturers will need to do their own research into other products on the market in order to determine if theirs is unique.
Whether the device is safe or effective. This can only be determined after a long and rigorous testing process, and the FDA will not speculate here. They will need to see the results of multiple studies in compliance with other FDA regulations.
Final determinations regarding the class of the device. The development and regulatory process may reveal new functions for a device or prove proposed functions infeasible, meaning that a device’s class may change between a 513(g) request and final approval.
Whether a manufacturer is authorized to market a device. This is another step that will have to wait until later in the regulatory process.
What studies may be necessary for approval and marketing of a product.
Conclusion
The 513(g) application process is an important tool for manufacturers looking to determine the best course of action for the development of devices. Knowing exactly what a 513(g) application will and won’t tell a medical device developer is necessary for taking further regulatory steps, and getting clear guidance from the FDA can help developers avoid risky over investment in devices that aren’t likely to meet FDA approval. Especially in today's constantly-shifting regulatory environment with novel devices forcing the FDA to rethink existing regulations, staying informed about regulatory procedures and next steps is a big competitive advantage.
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