To 513(g) or not to 513(g)? That is the question

In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Sometimes, though, the question of classification defies an easy answer.  When a company is unsure if its product is a device, there are a number of resources that can provide the answer, such as the device regulations at 21 CFR parts 800 – 898; any of the databases that cover product classification; the list of products with 510(k) clearance, premarket approval, and de novo authorization; and/or device guidance documents.

Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information.

Section 513(g) of the FD&C Act established a mechanism for receiving FDA’s feedback on the classification and regulatory requirements that may be applicable to a device. The provision states:

Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.

 Upon receipt of the 513(g), FDA will assess whether the product meets the definition of a device under section 201(h) of the FD&C Act. If it does, the letter will also identify the device class, whether a premarket notification or premarket approval is required to market the device, and other pertinent information.

Before FDA can begin its review of a 513(g) Request for Information submission, the applicant must pay the user fee. For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. If the applicant has been certified as a small business by FDA, the fee is $3,650. (For comparison, a pre-submission is a written request for FDA feedback that is free. One can generally expect to hear back in about 70 days.)

While the FD&C Act gives FDA 60 days in which to review 513(g)s, FDA rarely meets that statutory deadline.  According to the latest MDUFA performance report, only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

Table 1 Requests for Information About Classification and Regulatory Requirements Applicable to a Device Type Under 513(g)

This poor performance is both disappointing and frustrating.  As an example, we filed a 513(g) request in December 2023. Three hundred forty-two (342) days later – and counting – we still have not received a response, even though FDA has, in response to our prodding, indicated numerous times that the review was almost finished.

The reality is that FDA simply does not prioritize 513(g) requests. They are not tracked in MDUFA performance reports, and FDA can lose the name of action without consequences. Moreover, unlike with IDE applications, where a missed deadline results in granting the IDE, nothing happens here if FDA misses the 60-day deadline here; the applicant must endure the whips and scorns of time.

Additionally, for unknown reasons, 513(g)s go through more layers of review than most other submissions. While 510(k)s are reviewed through the Office of Health Technology level, 513(g)s also include review from the Office of Regulatory Programs and sometimes even the Regulation, Policy, and Guidance staff. Each of these reviews involve discussions and research with subject matter and policy expertise. This extends the timeline before a sponsor can receive a formal determination from FDA. FDA is aware of the extended timeline and says it has been working through a backlog of submissions, most of which have been on the digital health front. Nevertheless, the drawn out process leaves applicants in a regulatory purgatory. Furthermore, in our experience, because 513(g) decisions tend to err on the conservative side, applicants are prone to suffering the slings and arrows of outrageous fortune.

If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA.  Alternatively, the company can present a justification for not being regulated and receive a free informal determination by sending an email to DeviceDetermination@fda.hhs.gov. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. Of course, FDA reserves the right to recommend a formal submission if the inquiry is complex. And unlike a 513(g) determination, this conclusion is not legally binding.

As shown by the table above, a considerable number of companies do choose to submit 513(g) requests. The primary reason, in our experience, is that companies believe they need a binding, official FDA determination their product is not a device. Yet this method has many drawbacks: cost, time, and uncertainty of a favorable response. Considering these downsides, it is challenging to make the case for submitting a 513(g) when there are other means for determining whether a product is a device. Thus, unless and until FDA changes its approach to 513(g) submissions, the answer to the age-old question should be “Not to 513(g).”