What a 513(g) Request for Information Actually Costs -- and How Long You Will Wait
If you are developing a novel medical device and trying to determine the right regulatory pathway before committing resources to a full submission, a 513(g) Request for Information may be one of the most underutilized tools in your regulatory strategy toolkit. It gives device companies direct access to FDA's thinking on how a device would likely be classified -- before spending months preparing a 510(k), De Novo, or PMA.
But the two questions every startup founder and VP of Regulatory Affairs asks first are simple: What does it cost? and How long will it take? The answers are more nuanced than most people expect, and getting them wrong can derail your development timeline.
What Is a 513(g) Request for Information?
Under Section 513(g) of the Federal Food, Drug, and Cosmetic Act, any person may submit a request to FDA asking the agency to identify the classification and the submission requirements that would apply to a specific device. The statutory authority is codified at 21 U.S.C. 360c(g), and FDA's implementing procedures are described in its guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, finalized in January 2023.
A 513(g) is not a pre-submission (Q-Sub), and it is not a classification decision. It is a formal request for FDA's current thinking on how a device would be classified under 21 CFR Parts 862 through 892. The response is informational, not binding -- but in practice, FDA's 513(g) responses are highly instructive and often shape a company's entire regulatory roadmap.
The User Fee: What You Will Pay
FDA charges a user fee for 513(g) submissions under the Medical Device User Fee Amendments (MDUFA). The standard fee applies to large companies; small businesses that qualify under FDA's small business fee reduction program pay a substantially reduced rate -- roughly a quarter of the standard rate. Because MDUFA fees are set annually and change every fiscal year, check FDA's current Medical Device User Fee rates page for the exact figures in effect when you file.
To qualify for the small business rate, you must submit a Small Business Determination request to FDA's Office of Small Business, Minority, and Civil Rights (OSMBCR) in advance. This determination must be renewed annually. The reduced fee can represent meaningful savings for pre-revenue startups, so it is worth pursuing before your first submission.
It is also worth noting that the 513(g) user fee is separate from any consulting, preparation, or filing costs your team incurs. Building a thorough, well-scoped 513(g) request -- one that gives FDA enough device description, intended use, and technological characteristics to respond meaningfully -- requires real regulatory expertise. A poorly scoped 513(g) response from FDA can leave you with less clarity than you started with.
FDA's Response Timeline: Statutory Deadline vs. Reality
By statute, FDA must respond to a 513(g) request within 60 calendar days of receiving a complete submission. This is a hard deadline codified in 21 U.S.C. 360c(g)(2).
In practice, FDA's Center for Devices and Radiological Health (CDRH) has historically been reasonably consistent in meeting this window, though complex devices -- particularly combination products, AI/ML-enabled devices, or first-of-a-kind technologies -- may require additional back-and-forth that extends the effective timeline. FDA may also issue an Incomplete or Refuse to Accept determination if the submission lacks sufficient device description or technological information, resetting the clock.
Key timeline considerations to plan around include:
- Submission preparation: A thorough 513(g) package typically takes two to four weeks to prepare properly, depending on how well the device is characterized internally.
- FDA acceptance review: CDRH conducts an initial review to confirm the submission is complete before the 60-day clock begins.
- Response receipt: Plan for approximately 75 to 90 calendar days from submission date to response receipt when accounting for acceptance review and administrative processing.
- Post-response analysis: Do not underestimate the time needed to interpret FDA's response and translate it into a concrete regulatory pathway decision.
When a 513(g) Makes Strategic Sense -- and When It Does Not
A 513(g) is most valuable when your device does not have an obvious predicate, when you are genuinely uncertain whether you fall under Class II or Class III, or when investors or partners require documented FDA classification guidance before committing capital.
It is less useful when a substantially equivalent predicate already exists and your 510(k) pathway is clear, or when your timeline is so compressed that a Pre-Submission (Q-Sub) with a broader pathway conversation would be more efficient. FDA's Q-Sub program allows for more interactive dialogue and can cover classification questions alongside testing strategy, clinical study design, and software documentation -- often making it a higher-value interaction for complex programs.
Some teams submit both: a 513(g) for a formal classification record, followed by a Pre-Sub to discuss submission strategy in depth. That sequencing can work, but it adds time and cost, so it should be deliberate and well-planned.
How to Write a 513(g) That Gets a Useful Answer
FDA's response quality is directly proportional to the clarity of your submission. At a minimum, a well-constructed 513(g) should include a precise intended use statement, a complete device description with technological characteristics, proposed indications for use, and a clear articulation of the specific classification question you need FDA to address. Vague submissions yield vague responses.
Referencing the applicable product code database, existing classification regulations under 21 CFR, and any relevant FDA guidance documents in your submission demonstrates regulatory sophistication and helps FDA route your request to the correct division quickly.
Bottom Line
A 513(g) is a relatively low-cost, time-bound mechanism for getting formal FDA classification guidance. With a modest user fee (reduced further for qualifying small businesses) and a 60-day statutory response window, it is one of the more efficient regulatory intelligence tools available -- but only when the submission itself is built with precision and strategic intent. Done poorly, it consumes time and money without advancing your program. Done well, it can accelerate your entire development roadmap and give investors documented confidence in your pathway.
At ADB Consulting and CRO Inc., Andre Butler and the team work with device startups and established manufacturers to build 513(g) submissions that generate actionable FDA responses -- and to interpret those responses within the broader context of your regulatory strategy.
Ready to determine the right pathway for your device before your next funding round or design lock? Book a free discovery call with ADB Consulting and CRO Inc. at adbccro.com and get a clear-eyed view of your regulatory options from day one.
For related guidance, see our device classification service.
Ready to Navigate the FDA Process with Confidence?
Book a free 30-minute discovery call with ADB's regulatory team to discuss your specific device and situation.
Book a Free Pathway Call