513(g) requests allow medical device manufacturers to obtain the FDA’s views about the classification and the regulatory requirements that are applicable to their particular device.
The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) established three regulatory classes for medical devices.1
In December 2019, the FDA issued guidance which established procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the FD&C Act that are submitted in accordance with section 513(g) of said act.2
513(g) requests will generally provide a manufacturer with the following information:
the agency's assessment of the generic type of device (e.g., classification regulation) that the device appears to be within (if any);
the class of devices within that generic type
whether a premarket approval, premarket notification 510(k), or neither is required in order to market devices of the particular class within that generic type;
other requirements applicable to devices of the particular class within that generic type;
whether a guidance document has been issued regarding the exercise of enforcement discretion over the particular class of devices within that generic type;
whether additional FDA requirements may apply2
The 513(g) Request for Information should contain a cover letter, a description of the device, a description of what the device is to be used for and any proposed labeling or promotional material for the device. The FDA will respond within sixty days of the receipt of a 513(g) request elucidating the classification and the applicable regulatory pathway to market the device.2
The standard fee for a 513(g) request is $5,061, the small business fee is $2,530, to qualify for the small business fee, the entity must be certified by the Center for Devices and Radiological Health (CDRH) as such.3
FDA's responses to 513(g) Requests for Information are not device classification decisions and do not constitute FDA clearance or approval for marketing. The most common method of seeking a classification decision is to submit a 510(k).2
A History of Medical Device Regulation and Oversight in the US. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states. Published 2019.
U.S. Food and Drug Administration. FDA And Industry Procedures For Section 513(G) Requests For Information Under The Federal Food, Drug, And Cosmetic Act. Rockville, MD; 2019.
Medical Device User Fee Amendments (MDUFA). U.S. Food and Drug Administration. https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa. Published 2021.