While the 513(g) process doesn’t directly determine a device’s classification, it can be a valuable tool for obtaining information that aids in classification decisions.Here’s how it works:Device Manufacturer submits a 513(g) request: You initiate the process by formally asking the FDA for information on the classification and applicable regulatory requirements for your device.FDA reviews and responds within 60 days: They evaluate your device’s description and intended use, referencing existing classification regulations and guidance documents.FDA provides a written response: Their response outlines:The device’s classification (if already established).The applicable regulatory requirements.Recommendations for further steps, such as submitting a 510(k) or De Novo request for formal classification.Remember, the 513(g) response is not a binding classification decision. It’s an informal guidance to help you navigate the process. However, it can be useful for:Confirming a suspected classification: If you’re relatively certain of your device’s class, the 513(g) response can provide reassurance and clarity.Obtaining information for a 510(k) or De Novo submission: The insights from the FDA can guide your preparation for these formal classification pathways.Resolving ambiguities: If you’re unsure about certain regulatory requirements or classification criteria, the FDA’s response can provide clarification.