510(k) Proposal Request Checklist: What to Include

510(k) proposals often come back priced wildly differently for what looks like the same job. In my view the problem is rarely the consultants. It is the request. When a request says "we need help with a 510(k) for our device," every bidder fills the gaps with their own assumptions. As a hypothetical, you could end up comparing a $15,000 literature-and-formatting job against a $90,000 job that includes testing strategy, a Pre-Submission meeting and a QMS gap assessment. Neither is wrong. They are just not the same thing.

This guide walks through what a medical device company should put in a request for proposal (RFP) or request for quote when hiring outside help on a 510(k). It is written so you can copy the headings straight into your own document.

Why does the quality of your proposal request matter?

A 510(k) is a demonstration of substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic Act, and the content requirements sit in 21 CFR Part 807, Subpart E (807.87 lists the information a 510(k) must contain, while 807.92 governs the content of the 510(k) summary). The FDA's Refuse to Accept (RTA) screening applies an acceptance checklist before substantive review starts, so a submission with missing elements can stall on day one. The FDA's guidance "Refuse to Accept Policy for 510(k)s" describes that screening process, and your consultant should be working from the current version.

A vague request gives you a vague proposal, and a vague proposal is where scope disputes start six weeks into the project. A precise request lets you compare bidders line by line.

What company background should the request include?

Open with a short profile so bidders can judge fit quickly. Include:

Company stage (pre-seed startup, funded startup, established manufacturer adding a new product line)
Whether you have a quality management system today, and whether it is certified to ISO 13485:2016
Headcount in regulatory, quality and engineering, and who the internal owner of the project will be
Target launch date and any external drivers, such as an investor milestone, a distributor contract or a tender
Prior FDA interactions: earlier 510(k)s, Pre-Subs, Additional Information requests, or none

If you have no QMS yet, say so plainly. The FDA's Quality Management System Regulation (QMSR), which amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, took effect on February 2, 2026, replacing the former Quality System Regulation (including the old 820.30 design controls section). Design control requirements now come through ISO 13485 clause 7.3 and apply to most Class II devices. A bidder who does not know whether you have a design history to draw on will either pad the price or leave the work out. If you are starting from nothing, our guide to building a QMS from scratch for a medical device startup explains the sequence.

How do you describe the device so bidders can scope it?

This is the section people rush, and it drives more of the price than any other. Give bidders:

Device description and intended use. Two or three sentences on what it does, who uses it and on which patients or body site. Include the draft indications for use statement if you have one.
Technology characteristics. Energy source, materials with patient contact, whether it is sterile or non-sterile, single use or reusable, and whether it contains software or connectivity.
Proposed classification and product code. State what you believe it is, and flag if you are unsure. The FDA's Product Classification database is searchable, and a device that falls under a classification regulation in 21 CFR Parts 862 to 892 tells a bidder a lot.
Development status. Concept, prototype, design freeze, or in production abroad.

Should you name a predicate in the request?

Yes, if you have one. A predicate device is a legally marketed device to which you compare yours to show substantial equivalence (the 510(k) summary discusses this comparison under 21 CFR 807.92). Tell bidders your candidate predicate and its K number, and whether you have any reference devices. If you do not have one, ask the bidder to include predicate search and selection as a priced line item. Also state whether you think a de novo request could be the better path, since that changes the whole engagement. Reconsider the pathway if no suitable predicate exists, if your intended use or technology differs in ways that raise new questions of safety and effectiveness, or if the device is high risk enough that a PMA may be expected. Ask bidders to say when they would recommend a Pre-Sub to settle this before authoring begins.

What technical scope should the request define?

Break the work into workstreams and ask each bidder to price them separately. A table makes bids easy to compare:

Workstream	What to ask the bidder to specify	Typical deliverable
Regulatory strategy	Pathway confirmation, predicate analysis, need for Pre-Sub	Strategy memo with substantial equivalence rationale
Pre-Submission (Q-Sub)	Who drafts, who attends the meeting	Q-Sub package and meeting minutes
Testing plan	Standards, labs, protocol review	Gap analysis and test protocol list
Biocompatibility	ISO 10993-1 evaluation approach	Biological evaluation plan and report
Software and cybersecurity	Documentation level, IEC 62304 alignment	Software documentation set
Risk management	ISO 14971 file support	Risk management plan, report
Labeling	Instructions for use, label review against 21 CFR Part 801	Reviewed labeling
510(k) authoring	Sections written vs. reviewed	Complete submission in eSTAR format
Submission and follow-up	eSTAR upload, response to Additional Information requests	Submission and response package

Which standards and guidance documents should you list?

Name the ones you already know apply, and ask bidders to add what they think you missed. Common candidates are ISO 10993-1 for biological evaluation, IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility, ISO 14971 for risk management, and IEC 62304 for software lifecycle processes. The FDA lists recognized consensus standards in its Recognized Consensus Standards database, and declarations of conformity to those standards can shorten the review. Ask each bidder whether they will use the recognized version.

If your device has software, mention it here.

What should the request say about testing and who pays for it?

Testing is where budgets blow up, so the request needs to be explicit. This guide does not offer price or timeline ranges per workstream, because they vary too much with device type, testing needs and consultant. Instead, ask every bidder to price each workstream and state its duration. Answer these questions:

Is the consultant expected to only plan testing, or to manage the labs?
Are lab fees and test article costs excluded from the fee? (They almost always are, and bidders should say so.)
Do you already have data, such as bench tests, animal studies or clinical data? Attach a list.
Is clinical data likely to be needed? If you do not know, ask the bidder for their reasoning.

One habit I recommend: ask each bidder to list the top three assumptions behind their price. If bidder A assumes no clinical data and bidder B assumes a small study, you have found the reason for the price gap before you sign anything.

How does your quality system fit into a 510(k) proposal?

A 510(k) does not require ISO 13485 certification, but you cannot ship a cleared device without a quality system that meets the FDA requirements. Post-QMSR, that means the regulation in 21 CFR Part 820, which incorporates ISO 13485:2016. Your request should say whether you want the consultant to also:

Run a gap assessment against ISO 13485:2016 and 21 CFR Part 820
Build or repair design controls and the design history file
Prepare for a certification audit, or an FDA inspection
Support supplier qualification for critical components

If your QMS work is part of the same engagement, ask for it to be priced as a separate phase. That keeps the submission timeline from being held hostage by procedure writing. For the design side, see our design controls resource, and for the connection between the quality system and the submission, how ISO 13485 supports your FDA 510(k) submission.

If you want both submission and QMS support, a consultant who handles both can align the design history file with the submission from the start. Say so and ask bidders to show how the phases connect.

What deliverables and timeline should you require?

Ask for deliverables by name, with acceptance criteria. "Draft 510(k)" is not a deliverable. "Complete eSTAR package with all sections populated, reviewed against the current RTA checklist, and signed off by the project lead" is one.

Cover these points:

Milestone schedule with dates or week counts from kickoff
Your own responsibilities and turnaround expectations, such as five business days for document review
How many review rounds are included for each document
Who submits to the FDA, and who holds the eSTAR file afterward
Post-submission support: the FDA's goal for a decision on a Traditional 510(k) is 90 FDA days under the MDUFA performance goals. That is a performance goal, not a statutory deadline. An Additional Information request places the submission on hold, which stops the review clock, and you generally have 180 days to respond before the FDA may consider the submission withdrawn. Ask whether responding to that request is in the fee or billed as an extra.

What commercial and contract terms should you request?

Fee structure: fixed price per workstream, time and materials with a cap, or a retainer. Ask for a not-to-exceed figure for any hourly work.
FDA user fees: state that these are paid by you directly. The fee amounts are published each fiscal year in the Federal Register, and small business status can reduce them, so ask whether the consultant will help you apply for it.
Change control: how scope changes are priced and approved.
Confidentiality and IP: who owns the submission documents, and NDA terms.
Termination and handover: what you receive if the engagement ends early.

How should you ask bidders to prove they are qualified?

Ask for specifics that can be checked. Request:

Examples of cleared devices in the same product code or a similar technology (K numbers are public, so you can verify them yourself)
Named team members and their roles on your project, not just the firm's general credentials
Relevant credentials such as RAC certification or lead auditor qualifications
Two references you can call
Their approach to eSTAR, and how they handle an Additional Information request

Be careful about vague claims. A consultant who says "we have submitted many 510(k)s" has told you nothing you can verify. A consultant who gives you three K numbers has. If you are also choosing someone for the quality system, our piece on choosing an ISO 13485 consultant has a parallel set of questions.

How do you score the proposals you get back?

Write your scoring criteria into the request so bidders know what matters. The weighting below is an example only, not a standard. Tie the weights to your project risk: the higher the technical or regulatory risk, the more weight experience and scope clarity deserve. A simple weighting works:

Criterion	Suggested weight
Relevant device and product code experience	30%
Clarity of scope and deliverables	25%
Team and availability	15%
Price and payment terms	20%
References and communication approach	10%

Adjust for your situation. For instance, if your biggest risk is an unfamiliar technology, weight experience higher. If you have a fixed budget, weight price higher. Just decide before you open the proposals, because it is surprisingly easy to rationalize the cheapest bid afterward.

The complete checklist

Copy this into your request:

[ ] Company profile, stage and project owner
[ ] Current QMS status and certifications
[ ] Device description, intended use and draft indications for use
[ ] Technology characteristics, including software, sterility and materials
[ ] Proposed classification, product code and candidate predicate (K number)
[ ] Development stage and design freeze date
[ ] Existing test data and clinical data inventory
[ ] Applicable standards and guidance known to date
[ ] Bidders' top three pricing assumptions
[ ] Workstreams to be priced separately
[ ] Testing responsibilities and cost exclusions
[ ] Pre-Submission expectations
[ ] QMS and design controls scope, if any
[ ] Deliverables with acceptance criteria, and who holds the eSTAR file after submission
[ ] Milestone schedule and your review turnaround
[ ] Post-submission support and Additional Information response terms
[ ] Fee structure, change control, IP and termination terms
[ ] Qualification evidence requested (K numbers, named team, references)
[ ] Scoring criteria and decision date
[ ] Bidder Q&A deadline and proposal due date

What mistakes do companies make when requesting a 510(k) proposal?

The most common one is asking for a price before deciding on the pathway. If you have not settled between a 510(k), a de novo request and a PMA, no bidder can price the work accurately. A second is hiding the fact that the QMS is immature, which comes back as a change order once the consultant finds out. A third is skipping the assumptions list, so nobody can tell why the bids differ.

The last one is quieter. Companies treat the proposal as a purchase and forget it is the start of a working relationship. The bidder who asks you good questions before quoting is often the one you want, even if the questions slow you down by a week. If you want a second set of eyes on your request before you send it, you can contact me directly.

Last updated: 2026-09-30

Frequently Asked Questions

What should a 510(k) request for proposal include?

It should include a company profile, device description and intended use, proposed classification and candidate predicate, existing test data, applicable standards, separately priced workstreams, deliverables with acceptance criteria, a schedule, contract terms, and scoring criteria.

Do I need ISO 13485 certification to submit a 510(k)?

No. A 510(k) does not require ISO 13485 certification. You do need a quality system that meets 21 CFR Part 820, which now incorporates ISO 13485:2016 through the QMSR that took effect February 2, 2026.

Are FDA user fees and lab testing costs included in a consultant's fee?

Usually not. FDA user fees are paid by the manufacturer directly, and lab fees and test articles are normally excluded. Ask each bidder to state these exclusions in writing.

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

The MDUFA performance goal for a Traditional 510(k) is a decision within 90 FDA days. The clock stops when the FDA issues an Additional Information request, so total calendar time is often longer.

Should the consultant handle both the 510(k) and the ISO 13485 QMS?

It can help, because the design history file and the submission draw on the same records. Ask for the QMS work to be priced as a separate phase so it does not delay the submission.