510(k) Consultant: Scope of Work and How to Choose

Most device companies hire a 510(k) consultant for one of two reasons. Either the team has never cleared a device and does not know what it does not know, or the team has done it before and simply does not have the hours. Both are legitimate. The trouble starts when the engagement is described as "help with our 510(k)" and nobody writes down what that means.

The pattern is common. A company pays for a submission, receives an Additional Information request partway through review, and discovers that the consultant's scope never included test planning, never included the predicate strategy, and never included responding to FDA. An Additional Information request stops the review clock, and the submitter has up to 180 days to respond, so the delay can run from weeks to several months depending on the testing involved. This guide is meant to prevent that. It covers what a regulatory consultant does at each stage, how to write a scope of work you can hold someone to, and how to vet candidates.

What Does a 510(k) Consultant Do?

A 510(k) consultant helps a manufacturer demonstrate to FDA that a new device is substantially equivalent to a legally marketed predicate device. The legal standard sits in section 513(i) of the Federal Food, Drug, and Cosmetic Act, and the procedural requirements for the submission are in 21 CFR Part 807, Subpart E. Content requirements are in 21 CFR 807.87, the 510(k) summary requirements are in 21 CFR 807.92, and FDA's decision process is in 21 CFR 807.100.

In practice the work falls into five buckets:

1. Pathway and strategy. Confirming that a 510(k) is the right route at all, and selecting the predicate and any reference devices.
2. Gap assessment and test planning. Deciding what bench, biocompatibility, electrical, software, sterilization, and clinical evidence you need before anyone spends money on a lab.
3. Authoring and assembly. Writing the submission sections and building the file, which since October 1, 2023 has generally meant the FDA eSTAR template for 510(k)s.
4. FDA interaction. Pre-Submission meetings, the Refuse to Accept screen, the substantive review, and Additional Information requests.
5. Readiness around the submission. Quality system alignment, establishment registration, device listing, labeling, and what happens after clearance.

A good consultant does not simply type up what you give them. In my view the most valuable thing they do is tell you early that your predicate will not hold, or that your intended use statement quietly pushes you into De Novo territory.

Is a 510(k) Even the Right Pathway?

This is the first question, and it is worth paying for an answer before anything else. A 510(k) is not the only route to market, and picking the wrong one costs months.

A consultant who answers the pathway question in a single email, without looking at your intended use, indications, and technological characteristics, is guessing. Intended use is the hinge. If your device does the same thing as the predicate with a different technology, that is a conversation about whether the differences raise new questions of safety and effectiveness. If your indications are broader than the predicate's, you may have a different intended use altogether.

What Is Included in a Typical Scope of Work?

Fees and durations vary too widely for a single figure, because they depend on device complexity, how much testing already exists, and whether you need a review or full authoring. As rough planning figures, a focused strategy or gap review often costs in the low thousands to low tens of thousands of dollars, and full authoring and submission support often costs tens of thousands, plus lab testing billed separately. Preparation commonly takes several months before submission, followed by the FDA review time described below. Treat these as illustrative and compare written quotes.

Here is how I would break an engagement into phases. You can buy phases separately or together, but you should always know which one you are buying.

Phase 1: Regulatory Strategy and Predicate Selection

Deliverables you should expect in writing:

• Product code and classification regulation identified, with the reasoning.
• A predicate and reference device analysis, including a side-by-side comparison of intended use, indications for use, technological characteristics, and performance.
• A risk-ranked list of the differences FDA is most likely to question.
• A recommendation on whether to request a Pre-Submission under FDA's Q-Submission program.

Predicate selection deserves real time. A predicate must be a legally marketed device, and a device that has been recalled for a design problem or has a complicated history is a weak foundation. Your consultant should search the 510(k) database, read the predicate's publicly available summary, and check whether it has been cleared under the same product code you are targeting.

Phase 2: Gap Assessment and Test Plan

This is where schedules are made or lost. The consultant reviews your design documentation and identifies the testing FDA will expect, which commonly includes some mix of the following:

• Biocompatibility under ISO 10993-1 and FDA's guidance on the use of that standard, driven by the nature and duration of body contact.
• Electrical safety and EMC to IEC 60601-1 and IEC 60601-1-2 for powered medical devices.
• Software documentation following FDA's guidance on content of premarket submissions for device software functions, along with IEC 62304 lifecycle processes where applicable.
• Cybersecurity documentation for cyber devices under section 524B of the FD&C Act.
• Sterilization and shelf life validation where the device is supplied sterile.
• Performance testing against recognized consensus standards or FDA special controls guidance for your product code.

A consultant should also tell you which tests are worth doing in-house and which require an accredited lab, and should review the lab's protocol before testing starts. Reviewing a protocol takes an afternoon. Repeating a test costs weeks.

Phase 3: Authoring and Assembly

The consultant drafts or edits the sections, builds the eSTAR file, and prepares the 510(k) summary or statement under 21 CFR 807.92 and 807.93. Ask who actually writes. Some firms put a senior person on the sales call and a junior person on your file, which is not necessarily wrong, but you should know and the senior person should review.

Also confirm who owns the work product. You should receive the final eSTAR file, the source documents, and the test reports, not just a PDF.

Phase 4: Submission and FDA Interaction

After you pay the user fee and submit, FDA performs an administrative Refuse to Accept review, which under FDA's RTA policy for 510(k)s is aimed at the first 15 calendar days. Then comes the substantive review, which under the MDUFA performance goals is targeted at 90 FDA days (days on which FDA, rather than the submitter, holds the file). FDA days do not count while the clock is stopped for an Additional Information request, and the submitter generally has 180 calendar days to respond before the submission is considered withdrawn.

Your scope should state whether the consultant will:

• Serve as the official correspondent, or support you as the correspondent.
• Draft the response to any Additional Information request, and whether that is included or billed hourly.
• Attend or prepare you for interactive review calls.

The last point matters more than people expect. Additional Information requests are common, and a flat-fee quote that excludes them has quietly shifted the hardest part of the project back to you.

Phase 5: Quality System and Post-Clearance Readiness

A 510(k) clearance does not mean you are ready to sell. You still need your quality system in place, your establishment registered, and your device listed. Registration for device establishments is renewed annually, and the window runs October 1 through December 31, so build the renewal into your annual calendar. For help with that part, see our overview of FDA registration.

Where Does 21 CFR 820.100 Fit In?

Many teams still cite "21 CFR 820.100", which makes it a useful vetting test: a good consultant should know it is out of date. That section was the corrective and preventive action requirement of the old Quality System Regulation. FDA's Quality Management System Regulation final rule took effect on February 2, 2026, and it replaced most of Part 820 by incorporating ISO 13485:2016 by reference. Under the new framework, corrective action and preventive action are addressed through ISO 13485:2016 clauses 8.5.2 and 8.5.3.

Why does that matter for a 510(k)? Because FDA does not require a quality system inspection to clear a 510(k), but your design controls and CAPA process still have to be real by the time you ship. A consultant who is still writing procedures that cite 820.100 as the governing requirement is working from an outdated playbook. Ask them how they handled the transition, and treat a vague answer as a reason to keep looking.

What Should You Not Expect From a Consultant?

It is worth setting expectations plainly, because the disappointment usually comes from here.

• A guaranteed clearance. No honest consultant can promise one. FDA makes the decision under 21 CFR 807.100 on the evidence in the file.
• Data you have not generated. A consultant can design the test plan, but cannot invent performance data or clinical evidence.
• A fix for a weak predicate. Good strategy narrows risk. It does not turn a different intended use into the same one.
• Substitute accountability. The submitter certifies the truthfulness and accuracy of what is submitted under 21 CFR 807.87(k). Your name is on it, so read what is sent in your name.

How to Choose a 510(k) Consultant

For a broader look at hiring any FDA advisor, our piece on how to choose the right FDA consultant goes through the general questions. For 510(k) work specifically, these are the ones I would ask.

Do They Have Experience in Your Product Code?

Device 510(k)s are not interchangeable. A consultant who has cleared orthopedic implants may have little feel for a software-driven diagnostic, and the test expectations are different. Ask for their experience with your product code or at least your device type, and ask what FDA guidance documents govern it. If they cannot name the relevant special controls or guidance without looking it up, keep looking.

Can They Show You a Real Deliverable Format?

Ask to see a redacted gap assessment or predicate comparison table. You are not asking for confidential client data, only the shape of the work. A consultant who has a clear template is usually a consultant who has a clear process.

Who Does the Work?

Ask who will be on your project, what their role is, and how many hours the senior reviewer commits. Credentials in regulatory affairs, such as RAC certification, and in quality, are useful signals, but they do not replace relevant device experience.

How Do They Handle FDA Interaction?

Ask whether they will join Pre-Sub meetings and interactive review calls, and whether they have a view on when a Pre-Sub is worth the delay. I think the right answer is "it depends on how much novelty is in the device," and a consultant who always says yes or always says no is selling a service, not giving advice.

How Is the Fee Structured?

I am wary of anything tied to clearance. It creates exactly the wrong incentive when the honest advice is "do not submit yet."

Do They Understand Your Quality System?

A consultant who only knows submissions may miss the fact that your design history file cannot support the claims in the file. The best ones ask early about design controls, risk management under ISO 14971, and your supplier controls, because gaps there surface during review or inspection.

Red Flags Worth Walking Away From

• A promise of clearance or a guaranteed timeline.
• A quote delivered before they have read your intended use and indications.
• No written scope, or a scope that says "regulatory support" and nothing more.
• Reluctance to say who writes the submission.
• No clear answer on who owns the files at the end.
• Advice to market first and register later.

Checklist: Before You Sign

• The pathway question is answered in writing with reasoning.
• The scope names phases and deliverables, not activities.
• Additional Information request responses are either included or priced.
• Test plan review and lab protocol review are included.
• You know who writes, who reviews, and who is the FDA contact.
• You will receive the full eSTAR file and source documents.
• Quality system and registration readiness are addressed, even if out of scope.
• Payment milestones tie to deliverables, not calendar dates.

If you want a second opinion on a scope or a draft predicate strategy, our 510(k) consulting page explains how we work. I am happy to review a quote before you commit.

Last updated: 2026-10-14

Frequently Asked Questions

What does a 510(k) consultant do?

A 510(k) consultant helps a manufacturer show FDA that a device is substantially equivalent to a legally marketed predicate. The work usually covers pathway and predicate strategy, gap assessment and test planning, submission authoring in the eSTAR template, FDA communication including Additional Information responses, and readiness items like registration, listing, and quality system alignment.

Do I need a consultant to submit a 510(k)?

No. FDA does not require one, and the submitter is legally responsible for the submission under 21 CFR Part 807 either way. A consultant is most useful when you lack experience with your product code, have a difficult predicate question, or need extra capacity.

How long does FDA take to review a 510(k)?

FDA's MDUFA performance goal for most 510(k)s is a decision within 90 FDA days, after an initial Refuse to Accept screen aimed at 15 calendar days. The clock stops while FDA waits for a response to an Additional Information request, so calendar time is usually longer than 90 days.

Can a consultant guarantee 510(k) clearance?

No. FDA makes the substantial equivalence determination under 21 CFR 807.100 based on the evidence submitted. A consultant who guarantees clearance is a red flag.

Is 21 CFR 820.100 still in effect?

No. The QMSR final rule, effective February 2, 2026, replaced most of Part 820 by incorporating ISO 13485:2016 by reference. Corrective and preventive action is now addressed under ISO 13485:2016 clauses 8.5.2 and 8.5.3.