Purpose and scope of a 513(g) for a novel dental device

A 513(g) request is the mechanism to obtain FDA’s written feedback on the generic type of your device, its classification, and the applicable regulatory requirements under the FD&C Act, based solely on the information you provide about the device and its intended use. It is not used to resolve center assignment or product classification disputes (which are handled via Requests for Designation/Pre‑RFD), and FDA does not review safety/effectiveness data or provide testing recommendations in response to a 513(g) request ^{167168120122123121}.

What to include: the core 513(g) package

FDA’s 2024 513(g) procedures guidance outlines the content it expects in every request. For an early‑stage dental device, assemble the following:

1) Cover letter [identify the request and your questions]

• Clearly identify the submission as a “513(g) Request for Information.”
• Include the date; device name; requestor’s name, address, phone, email, and signature.
• List specific question(s) about classification and/or regulatory requirements you want FDA to answer.
• Note if no proposed labeling is available for your device or for a similar, legally marketed device.
• The request should be for a single product; multiple products require separate requests and separate user fees ¹¹⁹¹²³.

2) Description of the device [enable FDA to understand the technology]

• List of materials and components used in or with the device.
• Photographs and/or engineering drawings; a sample if practical.
• Operational principles (e.g., software/firmware involved).
• Type and amount of energy used/delivered (if any).
• Description of similar devices in U.S. commercial distribution, if available ¹²³.

3) Device uses / intended use [define clinical context precisely]

• Disease or condition the device is intended to diagnose, treat, prevent, cure, or mitigate.
• Prescription vs. over‑the‑counter status.
• Body part or tissue the device contacts or affects.
• Frequency/duration of use; physiological purpose (e.g., removes material, supports prosthesis).
• Patient population and environment of use ¹²³.

4) Labeling [or a statement that none is available]

• Proposed device labeling and any promotional material available.
• If helpful, include labeling/promotional material of a similar, legally marketed device.
• Any other labeling related to patient use ¹²¹.

5) User fee and administrative items

• Include payment of the required 513(g) user fee; FDA will not accept/review the request without it ¹¹⁹.
• Include the completed Medical Device User Fee Cover Sheet (FDA Form 3601) with the request, so FDA can determine fee applicability and track payment ^{209210211212213214}.

6) Submission method and change control

• Follow the submission routing appropriate to your center; for Q‑Submissions (which include 513(g)), FDA requires an eCopy and recommends submission via the CDRH Customer Collaboration Portal to ensure correct login/routing ^179180181.
• After submission, additions or modifications (e.g., new uses, technologies, or questions) are treated as a new 513(g) request and require a new fee ¹²¹.

Additional elements that strengthen a 513(g) when no clear predicate exists

While the 513(g) response is limited to classification and regulatory requirements, providing thorough, classification‑relevant context helps FDA give you precise feedback:

• Proposed classification regulation number and device class, if you have a reasonable hypothesis based on your research ⁹⁴.
• Proposed or candidate product code(s), if known; if none fits, say so. FDA uses your information to assess the device’s generic type and applicable premarket submission requirements ¹⁵⁶¹⁵⁵.
• Prior FDA interactions about the device (Q‑Subs, 513(g)s, IDEs, 510(k)s, De Novos, PMAs/HDEs); include submission numbers and a short summary so FDA understands history and current questions ⁹¹.
• References to relevant literature and any voluntary consensus standards you believe apply (including FDA‑recognized standards), to help FDA interpret your technology and intended use in an established regulatory context ⁹¹⁹⁴.
• A concise statement of your goals for this 513(g) interaction (e.g., “Request FDA’s view on classification and applicable premarket pathway for [device]”) to focus FDA’s response ⁹¹.

Dental‑specific details to emphasize inside your description

There are no unique, 513(g)‑specific requirements for dental devices; FDA applies the same 513(g) process across device types ^{120122119123121124168167}. However, for a dental device with no clear predicate, the following details make your intended use and technological characteristics clearer for classification purposes:

• Materials and patient contact: Identify all patient‑contacting materials, the oral tissue type (mucosal membrane, enamel/dentin, bone), and contact duration category (e.g., limited/short‑term) because these elements are central to defining the device type and context of use (even though FDA does not review biocompatibility data in a 513(g)) ¹²³.
• Reprocessing/sterility: If the device is reusable or sterile, describe whether and how it is reprocessed or sterilized and where it is used clinically; such context often differentiates device types in dental regulations ¹²¹¹²³.
• Energy and software: Describe any energy delivery (air/electric/thermal/light) and software/firmware functions (including principle of operation), as these technological characteristics influence classification ¹²³.
• Similar legally marketed devices: If any exist (even adjacent in scope), describe them and explain key differences in intended use or technology so FDA can assess whether an existing regulation may apply ¹²³.

Note: Do not expect FDA to review safety/effectiveness or testing plans in 513(g). For test plans, clinical strategy, or De Novo readiness, use a Pre‑Submission; classification and regulatory‑requirement questions belong in 513(g) ^{120122123121167168307309}.

Questions to ask FDA explicitly in your 513(g)

Frame clear, classification‑focused questions in your cover letter (examples):

• Into what generic type and regulation (21 CFR part and section) does FDA believe this device falls, based on the described intended use and technological characteristics? ^120122123121
• What is the likely device class (I, II, or III), and what regulatory pathway applies (e.g., 510(k), De Novo, PMA), including whether the device is exempt (if Class I or II exempt)? ^120122123121
• If applicable, what special controls would apply to this device type? ^120122123121
• Are there any similar, legally marketed devices (or product codes) FDA considers most relevant to this device’s classification? ¹²³

FDA’s 513(g) responses provide their assessment of device type/classification and applicable regulatory requirements based on your submission; they do not review or endorse test plans, nor do they resolve inter‑center assignment disputes ^{120122123121167168}.

Administrative mechanics and timing

• User fee and Form 3601 must accompany the request; otherwise FDA will not accept it for review ^{119209210211212213214}.
• One product per 513(g); file separately (and pay separate fees) for distinct products ¹¹⁹¹²³.
• If you later add new uses, technologies, or questions, FDA treats that as a new 513(g) filing with a new fee ¹²¹.
• For Q‑Submissions (inclusive of 513(g)), use an eCopy and consider the CDRH Customer Collaboration Portal to facilitate correct login and routing ^179180181.
• FDA generally issues a confidential written response within about 60 days of receipt, outlining its views on classification and regulatory requirements ⁴³.

When not to use a 513(g) (and what to use instead)

• Do not use 513(g) to dispute center assignment or to resolve borderline drug/device/biologic classification issues; use an RFD or Pre‑RFD for those topics ¹⁶⁷¹⁶⁸.
• Do not expect testing, clinical, or detailed regulatory strategy feedback (e.g., recommended performance testing, clinical study design, or De Novo evidence expectations) in a 513(g). Use a Pre‑Submission for those discussions; FDA encourages Pre‑Subs for novel devices and De Novo planning ^{167168307687170}.

Putting it together for an early‑stage dental device with no clear predicate

In practice, your 513(g) package should enable FDA to understand the intended clinical use and the technological characteristics of your novel dental device so it can advise on:

• The most appropriate classification regulation and device class, and
• The applicable premarket pathway (e.g., 510(k), De Novo, PMA) and any special controls that would apply to the device type ^120122123121.

Because there is no clear predicate, it is especially important to:

• Provide a precise, bounded intended use (patient population, oral tissues contacted, environment of use, duration of use) ¹²³.
• Describe the full technology stack (materials, components, energy/software, accessories) and how it works in the mouth ¹²³.
• Identify any similar marketed devices and explain how your intended use or technological characteristics differ; propose a candidate regulation/product code if you have a reasonable basis ^12394156155.
• Include labeling drafts if available, or note that none exist yet ¹²¹.
• Keep test data out of scope for 513(g), but be prepared to seek specific testing/clinical feedback via a Pre‑Sub if FDA points you toward a De Novo or 510(k) pathway ^{120122123121167168307}.

Expected outcome and next steps

• FDA’s 513(g) response will indicate the Agency’s current view of the device’s generic type, classification, and the applicable regulatory requirements (e.g., 510(k), De Novo, PMA, or exemption), based on the information you provided ^120122123121.
• If FDA indicates there is no suitable predicate and suggests a De Novo pathway is appropriate, follow up with a Pre‑Submission to obtain detailed feedback on testing and evidence expectations before filing a De Novo request ^{6869707172167307}.
• If FDA identifies a predicate or a classification regulation that fits, plan for the corresponding premarket submission (or exemption) and use a Pre‑Submission if you need detailed feedback on testing plans, labeling, or clinical protocols ^167168179.

Checklist you can use

• Cover letter: identify “513(g) Request,” single product, specific classification questions, contact info, date, signature ¹¹⁹¹²³.
• Device description: materials, components, drawings/photos, energy/software, similar marketed devices ¹²³.
• Intended use/uses: condition(s), Rx/OTC status, body site/tissue, frequency/duration, physiological purpose, population, environment ¹²³.
• Labeling: device labeling/promotional materials, or note if not available; include similar device labeling if helpful ¹²¹.
• Administrative: user fee paid; FDA Form 3601 attached; eCopy/portal routing; understand that additions require a new request/fee ^{119209210211212213214179121}.
• Optional but helpful for novel/no‑predicate devices: proposed regulation/product code; prior submission history; applicable standards/literature; concise statement of submission goals ^9491156155.

Key implications

Preparing a 513(g) request that is accurate, complete, and focused on intended use and technological characteristics enables FDA to deliver actionable classification and pathway feedback quickly. For a novel dental device without a clear predicate, combining the required 513(g) elements with a precise description of dental context (materials, tissue contact, reprocessing, energy/software) will help FDA determine whether your device fits within an existing regulation or should proceed via De Novo, while reserving detailed testing/clinical design questions for a subsequent Pre‑Submission ^{120122123121167168307}.