FDA 513(g) Regulatory Clarification Support
Practical RA supports manufacturers with FDA 513(g) submissions to obtain formal feedback on device classification and applicable regulatory requirements.
Why 513(g) Requests Matter
For novel or borderline devices, regulatory classification may not be immediately clear. A 513(g) request allows manufacturers to obtain FDA’s formal opinion on device classification, applicable regulations, and submission requirements before committing to a specific regulatory pathway.
Uncertainty around classification can lead to inefficient planning, unnecessary data generation, or selection of an inappropriate submission route. A 513(g) request helps reduce this uncertainty by providing written feedback directly from the Agency.
To be effective, a 513(g) submission must clearly describe the device, its intended use, and the specific regulatory questions being asked. Poorly framed questions or insufficient device description can result in ambiguous responses that do not resolve the underlying regulatory uncertainty.
513(g) feedback is particularly valuable for devices that do not clearly align with existing product codes or where multiple regulatory pathways may be possible. While the response is not a clearance or approval, it provides important regulatory insight that can inform subsequent strategy decisions.
How Practical RA Can Support
Practical RA provides support for 513(g) submissions, including:
- Assessment of whether a 513(g) request is appropriate
- Drafting of device descriptions and regulatory questions
- Submission preparation and coordination
- Integration of FDA feedback into regulatory strategy
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
