Essential Components of a Strong 513(g) Request Package

What to Include in a 513(g) Request – Required Components

Build a complete FDA 513(g) Request with all required elements—cover letter, detailed device description, intended use, labeling, admin details, and proof of fee payment—to ensure clarity, avoid delays, and receive accurate classification feedback.

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A successful 513(g) Request for Classification is one that provides the FDA with all the information needed to understand your device and its context. Incomplete or vague submissions could delay the response or result in less useful feedback. This section outlines the required components and recommended content to include in your 513(g) package, ensuring it meets FDA’s expectations:

Cover Letter

The cover letter is the front page of your request and arguably the most important single document. It should:

Identify the Submission:
Clearly state that this is a “513(g) Request for Information” under the FD&C Act. This wording alerts FDA staff to route it appropriately.
Include Request Details:
List the date of the request and the name of the device in question. For example: “Device Name: ABC Therapeutic Widget; Date: January 15, 2025.”
Pose the Classification Question:
Explicitly mention that you are seeking information on the device’s classification and applicable requirements. For instance, “We are requesting FDA’s determination of the class in which the above device has been classified and the regulatory requirements (if any) applicable to this device, per Section 513(g).” This aligns with the statutory language (classification and requirements) to keep the scope clear.
Contact Information:
Provide the name, title, and full contact details (address, phone, fax, email) of the requestor or primary contact person. FDA will use this for any correspondence, including mailing the response letter. It’s best to use a single point of contact to avoid confusion (footnote 9 in FDA guidance notes to provide one contact for the request).
Signature:
The letter must be signed by the requestor or an authorized representative of your organization. This signature attests that the information is truthful and that you are indeed requesting this information formally. Unsigned submissions could be considered incomplete.
Summary of Contents:
Optionally, you can bullet-list the enclosures or sections that accompany the letter (e.g., “Enclosed: Device Description, Intended Use statement, Proposed Labeling, User Fee cover sheet, etc.”). This helps the FDA reviewer ensure they have everything.

Tip: Keep the tone of the cover letter formal and to the point. It need not be lengthy – often one page suffices – but it should contain all the above elements. Think of it as the “executive summary” of your request.

Device Description

This is a detailed description of the device itself, usually a separate document or section following the cover letter. According to FDA guidance, the description should include relevant details such as:

Materials and Components:
What is the device made of or what components does it consist of? List key materials (especially if implants or if materials could affect regulatory status, e.g., drug-coated device) and main hardware/software components.
Principle of Operation:
How does the device achieve its intended purpose? Provide a summary of the device’s operational principles (for example, “The device emits ultrasonic waves to ablate tissue” or “It uses a machine-learning algorithm to analyze EKG signals”). If software/firmware is involved, mention it. If the device uses or delivers energy (electrical, ultrasonic, laser, etc.), describe the type and amount of energy.
Physical Description:
Describe the design and physical attributes. Include drawings, diagrams, or photographs if they help illustrate the device. Visuals can be very helpful to FDA (and the guidance explicitly allows including photos or engineering drawings). For instance, a photo can immediately convey size and form factor.
Comparable Devices:
If there are similar devices already on the market (even if not identical), describe how your device is similar or different. For example, “Our device is similar in principle to the XYZ device (510(k) K123456) but includes an additional sensor for temperature.” Providing a known product code or regulation number that you think might apply can be useful, though FDA will make the final call. If no similar device exists, that’s fine – but mentioning that context signals you did a comparison.

The device description can be a few paragraphs to a few pages, depending on complexity. The goal is to give FDA enough technical understanding of the product to categorize it correctly. Avoid proprietary jargon or internal project names; use clear terminology that FDA reviewers (who see thousands of device descriptions) will understand.

Intended Use / Device Uses

Include a section that clearly states the intended use of the device and any specific indications for use. FDA’s decision on classification is heavily driven by intended use (and indications), so this is critical. Provide details such as:

Medical Purpose:
What disease or condition is the device used for? (e.g., “intended to continuously monitor glucose levels in diabetic patients” or “for the treatment of chronic lower back pain through muscle stimulation”).
Target Population:
Who will use it or on whom? (e.g., pediatric patients with epilepsy, adult home-care patients, general population, healthcare professionals in a clinical setting, etc.).
Use Environment:
Where and how will it be used? (e.g., in a hospital ICU, at home by patients, in an ambulance, etc.).
Frequency and Duration of Use:
Is it a one-time use device, a reusable instrument, a long-term implant, etc.? How often or long is it used? (This can affect risk classification.).
OTC vs. Prescription:
State whether the device is intended for over-the-counter use by laypersons or only on the order of a licensed practitioner (prescription use). This distinction often affects regulatory controls.
Mechanism of Action (if not already covered):
If not obvious, you can describe how the device achieves the intended medical effect (though this might overlap with device description).

By clearly articulating intended use, you help FDA align your device with the correct regulation (since the Code of Federal Regulations classifies devices largely by intended use). Ambiguity here can lead to misclassification, so be precise and comprehensive.

Labeling and Promotional Materials:

FDA encourages including any proposed labeling (instructions for use, package labels) or promotional materials (brochures, website excerpts, advertisements) you have for the device. Why is this important? Because labeling contains the claims and instructions that define the device’s use. Even if you only have drafts or mock-ups, providing them can clarify how you intend to position the product. For example, labeling will show if you claim the device diagnoses a disease versus just monitors a symptom – a key classification point. If you have identified a similar legally marketed device, include examples of its labeling too, if available, especially if you are claiming equivalence or similarity. If no labeling exists yet (perhaps you are early in development), at least describe what you anticipate the labeling will state about the product’s use. Note: any patient-related labeling or information (like user guides, patient brochures) should also be provided if relevant (footnote references suggest including any labeling related to patient use).

Administrative Details

In addition to the core elements above, make sure to include the following administrative components in your 513(g) request package:

User Fee Confirmation:
As detailed in the previous section, attach the User Fee cover sheet or proof of payment for the 513(g) fee. FDA will check that the fee was paid; including the proof in your submission can expedite this verification.
Single Device Focus:
Ensure your request only addresses one device (or one product family) and its classification. If you inadvertently included multiple distinct devices or questions, FDA may consider parts of your request outside the scope. For example, don’t ask about two unrelated devices in one letter. Each device should be a separate request (with its own fee) if you have more than one product to inquire about.
References to Prior Communications:
If you have previously corresponded with FDA about this product (say, through an email or the Division of Industry and Consumer Education, or a Pre-Sub meeting), you can reference that in the cover letter or an appendix. This is not required, but if, for instance, FDA had suggested you submit a 513(g) after an earlier inquiry, referencing that context can be helpful.

Optional: Device Sample (If Feasible)

While not commonly done, FDA’s guidance notes you may submit samples of the device, if practical, and they will be returned upon request[42][36]. This usually applies to simpler devices (e.g., a sample of a surgical instrument or a piece of hardware). For most electrical or complex devices, photos or schematics suffice. If you do send a sample, coordinate with FDA first and label it clearly with your request so it’s handled properly.

By including all the above components, your 513(g) request will be comprehensive and robust. FDA reviewers will have a clear picture of your product and be able to efficiently identify the applicable classification or requirements. A well-prepared submission not only gets you a faster answer but often a more informative answer, because FDA can tailor their response to the details you provided (e.g., citing the specific regulation or guidance that fits your described device). Missing elements, like an unclear intended use or lack of device description, could lead to a more generic response or a request for clarification, prolonging the process.

Quality and Clarity

Remember to write all documentation in clear, professional language. Avoid marketing hype in the request content – be factual and objective in describing the device. FDA’s classification determination will hinge on facts, not on persuasive language. Double-check that the device description and intended use statements are consistent with each other and with any labeling provided (no contradictions). Consistency will reinforce the clarity of your request.

Final Checklist Before Submission

Use this quick checklist before sending off the package:

By ticking all these boxes, you set the stage for FDA to provide the classification guidance you need. In the next subpage, we will discuss what happens once your request is in – covering FDA’s review timeline and the typical outcomes you can expect from a 513(g) response.

Not sure if your 513(g) request has all the necessary components? Contact ADBC CRO. Our team can review your 513(g) package for completeness and clarity, helping to maximize the usefulness of FDA’s response.

Contact Us for 513(g) Submission Review

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