Step-by-Step Process for Filing an FDA 513(g) Request

Step-by-Step Process for Submitting a 513(g)

Discover the structured process for filing an FDA 513(g) Request. From preparing your device description and drafting the cover letter to paying user fees, submitting electronically, and receiving FDA’s response, this guide ensures a smooth classification inquiry.

← Back to 513(g) Request for Classification

Submitting a 513(g) Request for Classification involves a series of well-defined steps to ensure your inquiry is accepted and processed promptly by the FDA. Below is a structured guide through the process, from preparation to FDA’s receipt of your request:

Prepare Your Device Information

Begin by gathering and organizing all pertinent information about your device. You should be ready to describe the device in detail – what it is, how it works, its intended use, and any unique features. It’s helpful to have a concise device description and a statement of the device’s intended medical use before you start writing the request. You will use this information in both the cover letter and the main description section of the submission (see Step 3). This preparation also includes identifying any similar legally marketed devices, as this context can assist FDA’s assessment. Essentially, you want to be equipped to answer: “What is my product and what do I want FDA to tell me about its classification?”

Determine the Specific Question(s)

A 513(g) request must focus on classification and regulatory requirements. Be clear on what you are asking FDA. Commonly, the question is: “Under what classification and regulatory requirements would this device fall?” If you have a specific point of doubt (e.g., “Is my product considered a Class II device requiring a 510(k), or is it class I exempt?”), formulate that query explicitly. Make sure your question is in scope – questions beyond device classification or applicable requirements are not appropriate for 513(g). For instance, do not ask what testing is needed for approval (that would be out of scope and more appropriate for a Pre-Submission). Keep the focus on “what is my device’s classification and what requirements apply under the law?”

Write the 513(g) Cover Letter

The cover letter is a critical component of your submission. It formally identifies your inquiry as a “513(g) Request for Information” and provides an overview of the request contents. In your cover letter, include:

A clear title (e.g., “Re: 513(g) Request for Information – [Device Name]”).
The date of the request.
Your company name and contact information (name of requestor, mailing address, telephone, fax, email) – typically a single point of contact who will correspond with FDA.
The device name (and model, if applicable) and a brief identification of what the device is.
Your specific questions concerning the device’s classification and applicable requirements. For example: “We request FDA’s determination of the classification of [Device Name] and whether a 510(k) is required for marketing.”
A statement that the submission is a “Request for Information under section 513(g)” of the FD&C Act (to avoid any ambiguity).
Any reference to enclosures in the package (like device description document, labeling samples, etc.).
The signature of the requestor or an authorized representative.

Make the cover letter succinct (often about one page) but ensure all required elements are present. A well-crafted cover letter helps FDA quickly route your request to the right team.

Compile the Request Content

Along with the cover letter, prepare the supporting documents that will answer FDA’s inevitable questions about your device. Typically, your 513(g) submission package will include:

Device Description:
A detailed description of the device’s design, components, and operation. Include what materials or components it’s made of, how it functions (mechanism of action), and any diagrams or photos if useful. For example, describe software elements, energy sources, or key technology involved. Mention any similar devices on the market, if known, and how your device is similar or different.
Intended Use and Indications:
A statement of the disease or condition the device is intended to treat or diagnose, the target patient population, and the environment of use (hospital, home, etc.). Also clarify if it’s intended for prescription use or over-the-counter. This helps FDA understand the context and risk level of the device.
Proposed Labeling or Marketing Material:
If you have any draft labels, instructions, or promotional material for the device, include them. Likewise, if you have examples of labeling from a similar legally marketed device, those can be very helpful. Labeling gives insight into the claims you intend to make, which directly impact classification. If no formal labeling exists yet, you might include a mock-up or a description of what you plan to claim.
Any Other Supporting Info:
While not always required, you can include things like technical specifications, or prior communications with FDA (if, say, you had an informal email exchange with FDA or a Pre-Submission meeting relevant to the classification question). Keep the submission focused – extraneous data (like full test reports) are usually not needed for 513(g) and won’t be reviewed for this purpose.

All documents should be well-organized and clearly labeled. The total package is often concise (FDA notes many 513(g) submissions are under 15 pages), focusing on information relevant to determining product type and regulatory class.

Pay the 513(g) User Fee

Before sending your request, you must pay the required user fee for a 513(g) submission. As of recent user fee amendments, all 513(g) requests incur a fee (the FDA will not process the request until the fee is paid). The fee amount is set annually; for example, FDA’s user fee schedule will list the 513(g) fee for the current fiscal year, and eligible small businesses can pay a reduced fee (approximately 50% of the standard fee) if they have obtained small business status. To pay the fee:

Go to the FDA User Fee website and locate the Medical Device User Fee section (MDUFA). Generate a User Fee Cover Sheet (Form FDA-3601) via the User Fee System, selecting the 513(g) Request fee. This cover sheet will give you a Payment Identification Number (PIN).
Pay the fee through one of the accepted methods (online payment by credit card or ACH is preferred; checks or money orders by mail are also options). Ensure you include the PIN and reference number so FDA can link your payment to your submission.
Once paid, include a copy of the User Fee cover sheet or payment confirmation in your 513(g) submission package. This proves to FDA that payment was made. Remember, FDA’s review clock won’t start until the fee is received[23], so doing this step correctly is crucial. If you are a small business claiming a reduced fee, you must have your Small Business Determination from FDA in advance of submission to qualify for the discount.

Submit the Request to FDA

With the packet prepared and fee paid, the next step is to send your 513(g) request to the FDA. FDA recommends electronic submission for efficiency. There are two primary ways:

eCopy or Electronic Submission Gateway:
Prepare an electronic copy (eCopy) of the submission on a CD, DVD, or flash drive according to FDA’s eCopy guidelines, or submit via FDA’s Electronic Submission Gateway if available. The FDA has introduced an electronic template called eSTAR (electronic Submission Template and Resource) for certain submissions, including 513(g)s, which guides you through preparing the request in an interactive PDF format. Using eSTAR (if you choose) can ensure all required fields are completed. Whether using eSTAR or a standard eCopy, include all documents (cover letter, device description, etc.) in PDF format.
CDRH Customer Portal (if available):
FDA’s CDRH may offer a portal for submissions. As of recent guidance, 513(g) submissions can be uploaded through the CDRH Portal (which was formerly the eSubmitter Pilot). Using the portal can simplify submission and provide immediate confirmation of receipt.

Alternatively, you can still submit in paper form (one complete hard copy) via mail or courier, especially if electronic methods are not accessible. If submitting by mail, address the package to the CDRH Document Control Center (DCC) (or CBER DCC for biologics-related devices), with clear labeling that it’s a 513(g) Request. The FDA guidance provides the current mailing address for the DCC on their website (keep in mind to check for the latest address before sending). Using a trackable shipping method is wise to confirm delivery.

FDA Acknowledgement

Once FDA receives your submission (and provided the user fee is paid), they will usually issue an acknowledgment of receipt. This might come as an email or letter confirming that the 513(g) request was received on a certain date and is under review. The 60-day response clock starts from the date FDA has both the request and the fee in hand. If any administrative issues are noted (for example, if something was missing or the fee wasn’t confirmed), FDA may contact the listed contact person for clarification. In most cases, if you followed the steps, the request will enter the review queue without issue.

Interact as Needed During Review

Typically, 513(g) requests do not involve back-and-forth interaction the way some submissions do. FDA’s review is usually internal and based solely on what you submitted. In some instances, FDA may reach out with a clarification question if something in your description is unclear, but you should not expect formal deficiency letters or anything extensive. It’s important to have provided a complete package upfront, as you generally cannot modify or add to a 513(g) request once it’s submitted. If you realize you left out crucial information after submission, you may need to submit a new request (and pay another fee), so double-check everything before sending.

Receive FDA’s Response

FDA will issue a written response to your 513(g) inquiry, addressed to the contact person in the cover letter. This response is typically a letter on FDA letterhead that directly answers your classification question. Step 9 is technically after submission, but it’s the culmination of the process – we cover the details of the FDA response and timeline in a later subpage. In brief, expect a letter within 60 calendar days that outlines whether your product is a device, what classification it falls into, and what regulatory requirements (e.g., 510(k), PMA) apply.

By following these steps diligently, you can navigate the 513(g) submission process smoothly. Thorough preparation and attention to FDA’s requirements will help ensure your request is accepted and addressed promptly. In the next section, we’ll delve into what exactly to include in your 513(g) request (the content and components), complementing the process overview with a content checklist.

Ready to submit a 513(g) request but unsure about the details? Contact ADBC CRO for step-by-step support – our regulatory experts can help you prepare a complete 513(g) package and guide you through the submission process with confidence.

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