FDA 513(g) Request for Device Classification & Regulatory Guidance
Get clarity on your device classification and regulatory pathway with the FDA’s 513(g) process, ensuring a smooth path to FDA clearance.
Understanding FDA Device Classification and the 513(g) Process
Classifying your device is the starting point for getting your device cleared for sale in the US. Your classification helps you find answers to many important questions, such as: Which regulatory pathway is appropriate for my device – 510(k), PMA, De Novo or something else? Is my product a device at all? Manufacturers hoping to clear their device for sale under the FDA must first find a device already on the market that is substantially equivalent to their own, known as a predicate. The classification of your predicate–Class I, II, or III-determines the classification for your device. Depending on your product’s intended use and indications for use, finding a predicate device can require many hours of searching FDA databases and you still might come up short.
When a clear predicate device cannot be identified, and you want to feel confident about your device classification and predicate before compiling your regulatory submission, Section 513(g) of the Food, Drug, & Cosmetic Act establishes a process for manufacturers to obtain a classification determination from the FDA. This allows you to confidently proceed with the regulatory process, saving you time in the long run.
How does the FDA 513(g) request for information process work?
To initiate the 513(g) process with the FDA, you must submit a written request to the FDA as well as pay a fee (the fee may be refunded if your request doesn’t qualify for the 513(g) mechanism). The FDA will provide a written response within 60 days. If the FDA determines your product is a device, they will provide the following in their response:
- Device type and classification
- Submission type (510(k), PMA, or neither)
- Applicable regulatory requirements
- List of available guidance documents that apply to your device class
The FDA will not, however, provide information about substantial equivalence, safety and effectiveness, or specific testing required for your device. A pre-submission meeting is needed to obtain FDA feedback on other requirements for your product.
Our templates come with 10 hours of guidance from our team of experts. We’ll walk you through how to customize each template. We also explain how to implement required methodologies and procedures, such as how to conduct a risk analysis and implement a risk management process according to ISO 14971. This option is ideal for manufacturers with in-house resources who want a running start.
Our FDA 513(g) classification consulting process
Before you invest in the FDA’s 513(g) program, it’s important to do your homework. Our team has decades of experience classifying medical devices for FDA clearance as well as working directly with the agency. We’ll help you get the most out of your 513(g) request and guide you through the next steps.
How we can help:
Initial assessment
We begin by conducting a thorough assessment of your medical device and its intended use. This initial step sets the foundation for the rest of the process.
Engagement with the FDA
We facilitate communication with the FDA and compose responses to any additional information requests.
Preparation of 513(g) submission
Our experts meticulously prepare the 513(g) submission, ensuring that all necessary information is included for the FDA’s review.
Customized action plan
Based on the FDA’s feedback, we develop a customized action plan to guide your next steps, ensuring that you are prepared to compile the recommended submission type.
With our expert help, you’ll make the most of your Q-sub or Pre-sub meetings with the FDA. Schedule a consultation and take the first step towards marketing your product in the US.
