Regulatory Services
When a device's regulatory classification is uncertain — because the intended use is novel, the technology crosses device categories, or the line between device, drug, and combination product is unclear — a 513(g) request asks FDA to provide a formal determination. It is the most reliable way to resolve classification uncertainty before investing in a development program or submission.
Clarify Your Device ClassificationClassification Strategy
Section 513(g) of the FD&C Act allows any person to request that FDA classify a device or provide information regarding the regulatory requirements applicable to a device. A 513(g) request is appropriate when: the device's classification cannot be confidently determined through existing classification regulations and product codes, the device incorporates elements of multiple device categories whose combined classification is unclear, the device's intended use creates uncertainty about whether it is a device, drug, combination product, or IVD, or the company needs a formal FDA determination to support regulatory strategy decisions or investor due diligence.
A 513(g) request is not always the best first step. In many cases, a pre-submission (Q-Sub) meeting request is more appropriate — particularly when the company also has questions about the submission pathway, required data, and other regulatory requirements that a 513(g) request alone won't address. We assess whether a 513(g) request, a Q-Sub, or a combination of both is the right approach for the device's specific classification question before recommending a path forward.
A 513(g) request must include a description of the device, its intended use, and the specific questions for which FDA's determination is sought. The quality of the questions determines the utility of FDA's response. Vague questions produce general answers that may not resolve the actual uncertainty. Specific, narrowly drawn questions about the device's regulatory status, classification, and applicable requirements produce specific answers that can be relied upon in making development and business decisions.
The device description in a 513(g) request must be comprehensive enough for FDA to make an informed classification determination — including the device's mechanism of action, the materials involved, the intended use population, the indications for use, and how the device interacts with the body. For novel technologies, we include comparison to existing classified devices to help FDA identify the closest classified analog and the classification rationale that would apply.
FDA's response to a 513(g) request provides the company's classification determination, the applicable regulatory class, the pre-market submission pathway (510(k), De Novo, or PMA), and often the applicable device-specific guidance documents. This information is the foundation of the regulatory strategy — it defines the submission type, the review standard, the performance testing that will be required, and the timeline from development to market authorization. We analyze 513(g) responses in the context of the company's development stage and resources to develop a realistic, resource-appropriate regulatory strategy.
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Classification determines the submission pathway, the review standard, and the development program required. Getting it right at the start is far less expensive than discovering you're in the wrong pathway after a 510(k) submission has been filed.