513(g) Requests for Classification
What is Section 513(g)?
Section 513(g) of the Federal Food, Drug, and Cosmetic Act offers a channel for device manufacturers to acquire insights from the Food and Drug Administration regarding the classification of their devices. As per this provision, a company can make a written inquiry to the secretary, who will respond in writing within sixty days, detailing the device’s classification and the relevant regulations.
Device manufacturers commonly utilize a 513(g) request to ascertain the applicability of regulations to their product and whether their device falls under the purview of 510(k) regulations. Such inquiries help in determining whether a 510(k) submission is necessary, especially if modifications to the device are planned. Furthermore, device manufacturers may opt for a 513(g) submission to identify the most efficient approval pathway for their device, thus streamlining the regulatory process.
The process of a 513(g) can take up to sixty days and costs a set amount (as of 2024; $6,528 standard / $3,264 small business).
When should a 513g request for information be submitted?
A 513(g) request for information should ideally be submitted at the outset of a device design project, particularly during the concept or feasibility phases. It’s crucial to initiate this process early to ascertain the appropriate regulatory pathway. Often, device companies inquire about whether to file a 513(g) or a pre-submission request when seeking clarification on testing requirements. However, if the device already has a known product classification code necessitating a 510(k) submission or if there’s an available Special Controls Guidance document for the product classification, a 513g submission is usually unnecessary. It is concerning that many companies pose this question after they’ve commenced device development, typically just before initiating design verification testing—a stage considered quite late in the design process and even too late for a pre-submission request. Thus, timing is critical, and initiating the 513g submission early in the design phase ensures a smoother regulatory pathway verification process.
How to Submit a 513(g) Application?
A 513(g) application can be submitted online. Applications must comprise a cover letter, a device description, details on its intended use, and proposed labeling and marketing materials. The cover letter should explicitly indicate that it is a 513(g) request, containing the request date, device name, requester’s name, contact details, and signature. Cover letters play a crucial role in the process as they allow manufacturers to pose queries or present arguments regarding potential regulatory categories for the device. This can expedite the response process and potentially incline the FDA to view the device favorably.
Requests won’t be processed until all fees, including facility registration fees, are paid. Notably, these fees may be refunded if the submitted request doesn’t meet the criteria for a 513(g) request.
Information to Include in a 513(g) Request
The 513(g) Request for Information should contain the following:
- Cover Letter
- The date of the request
- The name of the device
- Your specific question(s) concerning the class in which a device has been classified and/or the regulatory requirements applicable to a device
- The requestor’s name, address, telephone number, fax number, and email address
- The 513(g) requestor’s signature
- Description of the Device
- A list of materials and component used in/with the device
- Photographs, engineering drawings, and/or samples of the device
- A summary of the device’s operational principles
- A description of the type and amount of energy to be used or delivered by the device
- A description of similar devices in commercial distribution in the U.S.
- Device Uses
- The disease or condition with respect to which the device is to be used
- Prescription versus over-the-counter use
- Part of the body or type of tissue applied to or interacted with
- Frequency of use
- Physiological purpose (e.g., removes water from blood, transports blood, etc.)
- Patient population
- Any other labeling information related to the patient use of the device
- Labeling
Please submit any suggested labels and promotional materials for the device, along with those of a similar legally approved device if possible. If there are no proposed labels available for the described device or a similar legally marketed device, please indicate this in the cover letter.
- Additions to a 513(g) Request for Information
After the FDA has received your 513(g) Request for Information and the corresponding user fee, you are not allowed to amend this request by introducing new inquiries, applications, or technologies. Any such addition would be considered a new 513(g) request, requiring an additional user fee, and will be addressed separately.
What the FDA Will Provide in Response
The FDA will give feedback to the medical device company based on its classification assessment. If the product doesn’t meet the criteria for classification as a device, the FDA will notify the company. However, if the product meets the requirements, the FDA will provide information on its evaluation of the device’s type and class, along with any applicable requirements for its class.
Furthermore, the FDA will advise on whether a premarketing approval application (PMA), a 510(k) application, or neither is needed for the device. They will also indicate if any specific guidance documents have been issued for this device class and whether any additional requirements, such as those relating to radiation-emitting products, might apply.
What the FDA Will Not Provide
The FDA refuses to disclose details regarding the substantial equivalence, safety, efficacy, authorization for marketing, or required studies for approval and marketing of a medical device. It’s emphasized that any information provided in response to a 513(g) request doesn’t represent a final decision or action by the FDA.
In conclusion, a 513(g) request serves as a pivotal step for device manufacturers to navigate the regulatory landscape efficiently, emphasizing the significance of initiating the process early in the device design phase to ensure a smoother pathway towards compliance and approval. If you need any support towards 513(g) request submission, please contact us at info@accelgroups.com.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
