Classification is not a guess based on how sophisticated a device looks. Intended use, the classification regulation, and the product code matter.
The first thing I would do is slow down and identify the actual regulatory question. Start with the intended use and indications. Search FDA’s Product Classification Database for similar devices, check the regulation number and product code, then verify controls, exemptions, and any premarket requirements. That gives you something you can check, discuss, and defend rather than an answer based on memory.
Here is a simple example. A device used to monitor wellness is not automatically regulated like a device intended to diagnose a disease. The actual claims and intended use can change the analysis. That is why I would always ask for the intended use, the device description, and the relevant evidence before making a recommendation.
What does someone in RA actually do here? Often the junior person does not make the final decision. They research the official sources, compare possible routes, gather the right documents, flag gaps, and write a short rationale that a senior colleague can review. That is valuable work, even if you are not the final signatory.
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Try this exercise: Create a one-page classification rationale with the source links, assumptions, class, product code, and remaining questions. Keep it to one page. Add the source, date checked, assumptions, and unanswered questions. If your reasoning changes after checking the official material, that is learning—not failure. One important limitation: Do not assign a class based only on a product photograph or a competitor’s marketing copy. These decisions are specific to the product and market. A short internet post is a starting point, not a regulatory determination.