Manufacturers face many challenges, one of which is that device manufacturers must determine on which regulatory path to proceed when developing a device, and if the classification of the device (e.g., I, II or III) is unclear, things can get confusing and complicated fairly quickly.
As such, the Food and Drug Administration has established a mechanism in Section 513(g) of the Federal Food, Drug, and Cosmetic Act by which device manufacturers can obtain answers regarding how FDA would classify their device, thus determining the approval process. As such, understanding how to use the mechanism is important to device manufacturers.
What is Section 513(g)?
Section 513(g) of the Federal Food, Drug, and Cosmetic Act provides a means for device manufacturers to obtain information about the Food and Drug Administration's views regarding the classification of a device. According to the legislation, a company can submit a written request to the secretary. The secretary will provide a written reply regarding the classification of a device and the associated regulations within sixty days.
Device manufacturers typically submit a 513(g) request to determine whether the regulations pertain to a product and whether a device is subject to the 510(k) regulations. They may submit the request to ascertain whether they need to submit a 510(k) if they intend to modify a device.
Determining the least cumbersome mechanism to get a device approved may also be a reason for a device manufacturer to submit a 513(g).
How to Submit a 513(g) Application
Medical device companies should submit a 513(g) application in writing to the appropriate office and identify it as such. The application should contain a cover letter, a description of the device, a description of the indicated use of the device, any proposed labeling and marketing materials for the device.
The cover letter should identify the request as a 513(g) request for information. Also included should be the date of the request, the name of the device, specific questions regarding the class of the device, the requester's name and contact information, and the 513(g) requester's signature.
The Food and Drug Administration is required to collect user's fees for requests for information. As such, they may not accept a request for information until all of the fees have been paid, including facility registration fees.
When the Food and Drug Administration has received all of the fees owed, they will review the request for information. If the Food and Drug Administration determines that the request does not match the requirements of a 513(g) request, they will refund the user's fee.
What the Food and Drug Administration Will Provide in Response
The Food and Drug Administration will inform the medical device company if the product does not meet the requirements for classification as a device. However, if the product meets the requirements, the Food and Drug Administration will issue information regarding their assessment of the type and class of the device, and any requirements that apply to the class to which the device belongs.
They will also provide information on whether a premarketing approval application (PMA), a 510(k) application, or neither, is necessary. They will provide information on whether guidances on this particular class of device have been issued and whether any other requirements may apply (e.g., those regarding radiation-emitting products).
What the Food and Drug Administration Will Not Provide
The Food and Drug Administration will not provide information on whether the device is substantially equivalent. They will not provide information on the safety and efficacy of the device. They also will not make final determinations on the class of the device or authorizations to market the device.
The Food and Drug Administration will also not provide information on the type of studies necessary for approval and marketing of a product. Medical device companies should also understand that any information released in response to a 513(g) request does not constitute any final decision or action on the part of the Food and Drug Administration.
The 513(g) mechanism serves as a useful resource for device manufacturers determining the best course of action for development of devices. By understanding how to submit the information and what the Food and Drug Administration provides in response, device manufacturers can decrease the chances of making errors when choosing a development path and determining the classification of a device. Through use of the mechanism, device manufacturers can avoid wasting time and valuable resources as they prepare their applications for approval.
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