How Much Does a 510(k) Cost? Complete 2026 Budget Breakdown

Why Understanding 510(k) Costs Matters

Budget overruns are one of the most common reasons medical device startups delay or abandon their US market entry. The FDA 510(k) process is often described as the "faster, cheaper" regulatory pathway — and compared to a PMA, it is. But "cheaper" is relative. A single 510(k) can cost anywhere from $30,000 to over $500,000 depending on device complexity, and most first-time submitters significantly underestimate the total investment.

The FDA user fee is just the starting point. Testing, consulting, documentation, labeling systems, and recurring compliance costs add up quickly. Companies that plan for only the user fee find themselves scrambling for capital mid-submission, which delays timelines and increases costs further.

This guide provides a complete, data-driven cost breakdown for a 510(k) submission in FY 2026 (October 1, 2025 through September 30, 2026). Every figure comes from published FDA fee schedules, industry pricing data, and real-world submission experience. Use it to build an accurate budget before you start — not after you have already committed resources.

FDA User Fees: The Non-Negotiable Costs

The FDA charges user fees for premarket submissions under the Medical Device User Fee Amendments (MDUFA). These fees are set annually and adjusted for inflation. For FY 2026 (effective October 1, 2025 through September 30, 2026), the fees are as follows:

FY 2026 FDA Device User Fee Schedule

Submission Type	Standard Fee	Small Business Fee (25%)
510(k)	$26,067	$6,517
513(g) Request for Information	$7,820	$3,910
De Novo Classification Request	$173,782	$43,446
PMA / PDP / PMR / BLA	$579,272	$144,818
Establishment Registration (annual)	$11,423	$11,423 (no reduction)

Key observations for FY 2026:

• The standard 510(k) fee remains $26,067, unchanged from FY 2025
• The establishment registration fee jumped 23% — from $9,280 in FY 2025 to $11,423 in FY 2026. This is the most significant fee increase and affects every registered device establishment
• Small business eligibility requires gross receipts and revenues of $100 million or less (including affiliates). The small business fee is exactly 25% of the standard fee
• There is no small business reduction for establishment registration — all establishments pay the full $11,423

Budgeting tip: The establishment registration fee is annual and recurring. If you are budgeting for Year 1, include it. If you are budgeting for ongoing operations, plan for it every fiscal year (October through September).

When Fees Are Due

• 510(k) user fee: Paid at the time of submission via the FDA User Fee System (Pay.gov). Your submission will receive a Refuse to Accept (RTA) designation if the fee is not paid
• Establishment registration: Due annually between October 1 and December 31. All establishments must register and list their devices within the FDA's Unified Registration and Listing System (FURLS)

Who Qualifies as a Small Business?

To qualify for the small business fee reduction, your business (including all parent companies, subsidiaries, and affiliates worldwide) must have had $100 million or less in gross receipts and revenues during the most recent tax year.

The process requires submitting a Small Business Determination (SBD) request to the FDA, which includes:

• A cover letter requesting small business qualification
• A copy of your most recent federal income tax return (or equivalent for foreign entities)
• Documentation covering all affiliates and subsidiaries
• Processing typically takes 30-60 days

Submit your SBD request before you submit your 510(k). The FDA will not retroactively apply the small business fee.

Cost Breakdown by Device Complexity

The 510(k) user fee is just one line item. The total cost of bringing a device through the 510(k) pathway is driven primarily by device complexity — specifically, the amount and type of testing required, whether clinical data is needed, and how much professional regulatory assistance you engage.

Low Complexity: $30,000 - $75,000

Device examples: Manual surgical instruments, non-powered orthopedic tools, basic wound dressings, dental impression materials, simple catheters without coatings, tourniquets, examination gloves

Cost Component	Typical Range
FDA 510(k) user fee (standard / small business)	$6,517 - $26,067
Biocompatibility testing (ISO 10993)	$5,000 - $15,000
Performance / bench testing	$2,000 - $10,000
Submission preparation (internal staff)	$5,000 - $15,000
Labeling / UDI setup	$2,000 - $5,000
Establishment registration	$11,423
Total	$32,000 - $83,000

Low-complexity devices typically do not require powered functionality, software, sterilization validation, or extensive performance testing. The predicate landscape is usually well-established, meaning the substantial equivalence argument is straightforward. Many companies handle the submission internally if they have experienced regulatory staff.

Moderate Complexity: $100,000 - $175,000

Device examples: Powered surgical instruments, electrosurgical units, patient monitoring systems, diagnostic imaging accessories, infusion pumps, endoscopic devices, devices with software, devices requiring sterilization validation

Cost Component	Typical Range
FDA 510(k) user fee (standard / small business)	$6,517 - $26,067
Bench performance testing	$15,000 - $40,000
Electrical safety & EMC (IEC 60601 series)	$10,000 - $30,000
Biocompatibility testing (ISO 10993)	$10,000 - $25,000
Software documentation (IEC 62304)	$5,000 - $20,000
Sterilization validation (if applicable)	$8,000 - $20,000
Regulatory consulting / submission prep	$15,000 - $40,000
Labeling / UDI setup	$3,000 - $8,000
Establishment registration	$11,423
Total	$84,000 - $221,000

Moderate-complexity devices are where most first-time submitters encounter cost surprises. The testing requirements multiply quickly — a single powered device may need electrical safety testing, electromagnetic compatibility (EMC) testing, biocompatibility testing on patient-contacting materials, software lifecycle documentation, and potentially usability testing under IEC 62366-1.

Companies without dedicated regulatory staff almost always need external consulting for these submissions. The predicate selection, testing strategy, and substantial equivalence argument require experience that most engineering teams do not have in-house.

High Complexity: $175,000 - $500,000+

Device examples: Implantable devices (orthopedic, cardiovascular), devices with novel materials or coatings, combination products, devices requiring clinical data, AI/ML-enabled devices, devices with novel mechanisms of action

Cost Component	Typical Range
FDA 510(k) user fee (standard / small business)	$6,517 - $26,067
Extensive bench / performance testing	$30,000 - $100,000
Biocompatibility testing (ISO 10993, extended)	$15,000 - $50,000
Clinical data collection / literature review	$20,000 - $150,000+
EMC & electrical safety	$10,000 - $30,000
Software documentation (IEC 62304, advanced)	$10,000 - $40,000
Animal / cadaveric testing (if applicable)	$20,000 - $80,000
Regulatory consulting (full service)	$30,000 - $80,000
Multiple FDA interactions (pre-submissions)	$5,000 - $15,000
Labeling / UDI setup	$5,000 - $15,000
Establishment registration	$11,423
Total	$163,000 - $597,000+

High-complexity submissions often require multiple rounds of FDA interaction before the formal 510(k) is even submitted. Pre-submission meetings, while free in terms of user fees, carry significant preparation costs — your team needs to compile questions, supporting data, and briefing documents. Each pre-submission meeting typically requires 40-80 hours of regulatory and technical preparation.

If your device requires clinical data to support substantial equivalence, costs can escalate dramatically. Even a well-designed clinical study or systematic literature review to support a 510(k) can add $50,000 to $150,000 or more to the total budget.

Testing and Laboratory Costs

Testing is typically the largest variable cost in a 510(k) submission. The specific tests required depend on your device type, materials, intended use, and what recognized consensus standards apply. Below is a breakdown of the most common testing categories.

Biocompatibility Testing (ISO 10993 Series)

Biocompatibility testing evaluates the biological response to device materials that contact the patient. The ISO 10993 series defines the testing framework, and the required endpoints depend on the nature and duration of body contact.

Test Category	Typical Cost	When Required
Cytotoxicity (ISO 10993-5)	$1,500 - $3,500	Nearly all patient-contacting devices
Sensitization (ISO 10993-10)	$3,000 - $6,000	All patient-contacting devices
Irritation (ISO 10993-10)	$2,000 - $4,500	Surface-contacting devices
Acute systemic toxicity	$3,500 - $7,000	Internal / implant-contacting devices
Hemocompatibility (ISO 10993-4)	$5,000 - $15,000	Blood-contacting devices
Subchronic toxicity	$15,000 - $40,000	Implantable devices, long-term contact
Genotoxicity (ISO 10993-3)	$5,000 - $12,000	Permanent implants, some long-term devices
Implantation study	$20,000 - $60,000+	Implantable devices

Cost-saving strategy: Use a biological evaluation plan (BEP) upfront. A well-constructed BEP, guided by ISO 10993-1, can justify waiving certain tests based on material chemistry data, literature review, or prior testing history. This can save $10,000-$50,000 in unnecessary testing.

Electrical Safety and EMC Testing (IEC 60601 Series)

Any electrically powered medical device must comply with the IEC 60601 series. This is a non-negotiable testing requirement and one of the most expensive line items for powered devices.

Test	Typical Cost	Timeline
IEC 60601-1 (General safety)	$5,000 - $12,000	2-4 weeks
IEC 60601-1-2 (EMC)	$8,000 - $20,000	2-4 weeks
IEC 60601-1-6 (Usability)	$3,000 - $8,000	1-3 weeks
IEC 60601-1-8 (Alarm systems)	$2,000 - $5,000	1-2 weeks
Particular standards (60601-2-XX)	$3,000 - $10,000 each	2-4 weeks each

Important: Testing must be performed on a production-equivalent or final production unit. Testing on prototypes that do not represent the final device will be rejected by the FDA. Plan for a production-ready unit before scheduling tests.

Performance and Bench Testing

Performance testing demonstrates that your device meets its claimed specifications and performs as well as (or comparably to) the predicate device. The specific tests depend entirely on your device type.

Device Category	Typical Testing Cost	Examples
Surgical instruments	$2,000 - $10,000	Mechanical strength, fatigue testing, dimensional verification
Catheters / tubing	$5,000 - $20,000	Flow rate, burst pressure, tensile strength, kink resistance
Orthopedic implants	$15,000 - $60,000	Mechanical fatigue, wear testing, static/dynamic strength
Infusion / pump systems	$10,000 - $40,000	Flow accuracy, occlusion detection, air-in-line detection
Diagnostic / imaging devices	$15,000 - $50,000	Sensitivity, specificity, precision, accuracy studies
Software-only devices (SaMD)	$5,000 - $25,000	Verification testing, cybersecurity assessment, performance validation

Sterilization Validation

If your device is supplied sterile, you must validate the sterilization process. This is separate from biocompatibility and performance testing.

Sterilization Method	Typical Validation Cost	Timeline
Ethylene oxide (EO/EtO)	$15,000 - $35,000	4-8 weeks
Gamma irradiation	$10,000 - $25,000	3-6 weeks
Steam (autoclave)	$8,000 - $20,000	3-6 weeks
Packaging validation (ISO 11607)	$8,000 - $20,000	4-8 weeks

Sterilization validation and packaging validation are often quoted together. Budget $20,000-$50,000 for the combined package if your device requires sterile packaging.

Consulting and Professional Services

Most companies — especially first-time submitters — engage external regulatory consultants for some or all of the 510(k) preparation process. The level of engagement and cost varies widely.

Service Tiers and Pricing

Service Level	Typical Cost	What You Get
Advisory / review only	$5,000 - $15,000	Strategic guidance, predicate selection, submission review before filing
Submission preparation	$18,000 - $22,000	Full 510(k) document preparation from your test data and technical inputs
Full-service consulting	$30,000 - $80,000	End-to-end management — testing coordination, document prep, FDA correspondence, RTA response
Hourly consulting	$275 - $450/hr	Targeted expertise for specific issues

When You Need a Consultant

You should strongly consider professional regulatory assistance if:

• This is your first 510(k) submission
• Your device involves software, wireless connectivity, or AI/ML features
• You are uncertain about predicate device selection
• Your device involves novel materials or technologies
• You have limited in-house regulatory expertise
• You are a foreign manufacturer unfamiliar with FDA expectations

Cost-benefit analysis: A $30,000-$50,000 consulting engagement can easily save you $50,000-$100,000 in re-testing costs, resubmission fees, and timeline delays. The RTA rate for 510(k) submissions hovers around 30-40% — and most RTAs result from preventable formatting and completeness errors, not scientific deficiencies. An experienced consultant knows exactly what the FDA expects to see in each section.

Choosing a Consultant

When evaluating regulatory consultants, consider:

• Track record: How many 510(k)s have they submitted in your device specialty? Ask for success rates
• FDA familiarity: Do they have former FDA reviewers on staff or deep experience with the specific review branch?
• Scope clarity: Ensure the engagement letter specifies exactly what is included — test plan review, document drafting, FDA correspondence, RTA response, etc.
• References: Ask to speak with past clients, ideally those with similar device types

Hidden Costs Most Companies Overlook

Beyond the obvious line items, several costs catch companies off guard. These are not optional — they are required for legal marketing in the US.

US Agent Fees (Foreign Manufacturers Only)

If your establishment is located outside the United States, you must designate a US Agent as part of your establishment registration. The US Agent serves as the FDA's communication channel and must be available during US business hours.

Service	Typical Annual Cost
Basic US Agent (registration only)	$1,500 - $3,000/year
US Agent with regulatory support	$3,000 - $5,000/year
US Agent + import/distribution support	$5,000 - $10,000/year

This is a recurring annual cost for as long as your establishment remains registered.

Labeling and UDI System Setup

The FDA requires Unique Device Identification (UDI) on most device labels. Setting up UDI involves obtaining a labeler identifier from an FDA-accredited issuing agency (GS1, HIBCC, or ICCBBA), assigning product identifiers, and submitting data to the Global Unique Device Identification Database (GUDID).

Item	Typical Cost
GS1 company prefix (annual)	$500 - $3,500
UDI labeling system implementation	$3,000 - $10,000
GUDID data submission setup	$2,000 - $5,000
Label redesign and printing setup	$2,000 - $8,000
Total	$5,000 - $15,000

Annual Establishment Registration

This bears repeating because it is the most overlooked recurring cost:

• FY 2026 fee: $11,423 per establishment
• Due: October 1 - December 31 annually
• No small business reduction
• Consequence of non-payment: Your devices cannot legally be sold in the US. The FDA considers unregistered devices to be misbranded

This fee increased 23% from FY 2025 ($9,280). Plan for continued increases in future years.

Post-Market Surveillance Setup

After clearance, you are not done spending. Post-market requirements include:

Requirement	Typical Setup Cost
Complaint handling system	$3,000 - $10,000
Medical Device Reporting (MDR) procedures	$2,000 - $5,000
Post-market surveillance plan	$5,000 - $20,000
Quality system updates for US market	$5,000 - $15,000

Attorney and Intellectual Property Costs

If your device has patent implications, you may need legal counsel:

• Patent freedom-to-operate analysis: $5,000 - $25,000
• IP review for labeling claims: $2,000 - $5,000
• Corporate structure review for US market entry: $3,000 - $8,000

These costs are optional in the sense that the FDA does not require them, but they are prudent investments for most companies, especially those with novel technology.

Complete Hidden Costs Summary

Hidden Cost	One-Time or Recurring	Typical Range
US Agent (foreign mfg)	Recurring annual	$1,500 - $5,000/yr
UDI / labeling setup	One-time	$5,000 - $15,000
Establishment registration	Recurring annual	$11,423/yr
Post-market surveillance setup	One-time	$5,000 - $30,000
Attorney / IP review	One-time	$5,000 - $30,000
Total hidden costs (Year 1)	—	$28,000 - $92,000

Small Business Strategies to Reduce Costs

The FDA provides several programs specifically designed to reduce the financial burden on small manufacturers. If your company qualifies, the savings can be substantial.

Small Business Determination (SBD) Program

As outlined earlier, companies with $100 million or less in gross receipts qualify for the 25% reduced user fee rate. The savings for a standard 510(k):

• Standard fee: $26,067
• Small business fee: $6,517
• Savings: $19,550 (75% reduction)

How to apply: Submit an SBD request to the FDA's Division of Industry and Consumer Education (DICE) at least 60 days before your planned submission date. You will need your most recent federal tax return and documentation for all affiliates.

First PMA/PMR/BLA/PDP Fee Waiver

If your company has $30 million or less in gross receipts and has never received FDA approval for a PMA, PMR, BLA, or PDP, you are eligible for a one-time waiver of the PMA/PMR/BLA/PDP user fee. This does not apply to 510(k) fees, but it is important to know about if your regulatory pathway changes.

FY 2026 Registration Fee Waiver (New)

A notable change for FY 2026: establishments with $1 million or less in gross receipts AND demonstrated financial hardship may apply for a waiver of the $11,423 annual registration fee. This is a new provision and the specific application process is outlined in the FY 2026 fee guidance document.

Contact the FDA's Division of Industry and Consumer Education for current application procedures.

Third-Party Review Program

The FDA's Accredited Persons (Third Party) Review Program allows qualified third-party review organizations to conduct the initial review of eligible 510(k) submissions. The key financial benefit:

• No 510(k) user fee is charged for submissions reviewed under the Third Party Review Program
• The third-party review organization charges its own fee, but the total cost may still be lower
• Typical third-party review organization fees: $20,000 - $50,000
• The FDA still makes the final clearance decision

Eligibility: Not all devices qualify for third-party review. Class III devices, implants, and certain high-risk Class II devices are excluded. Check the FDA's list of eligible device types before pursuing this option.

Net savings comparison:

Option	Cost
Standard 510(k) + user fee	$26,067 (fee) + $18,000-$22,000 (prep) = $44,000-$48,000
Third-party review (no user fee)	$0 (fee) + $20,000-$50,000 (third-party review) = $20,000-$50,000

For low-to-moderate complexity devices that qualify, third-party review can be cost-neutral or cheaper, with the added benefit of typically faster review times (the FDA targets 30 days for third-party-reviewed submissions).

eSTAR Format

The FDA's eSTAR (Electronic Submission Template and Resource) is a free, PDF-based template that guides you through the 510(k) submission content. Using eSTAR:

• Is free — no licensing or software costs
• Is recommended (and increasingly expected) by the FDA
• Reduces the risk of RTA by ensuring all required sections are addressed
• Streamlines internal preparation by providing a structured framework

While eSTAR does not directly reduce costs, it reduces the risk of costly resubmissions by ensuring your submission is complete and properly formatted. As of late 2025, the FDA has signaled that eSTAR may become mandatory for all 510(k) submissions.

510(k) vs. De Novo vs. PMA: Cost Comparison

Choosing the right regulatory pathway is itself a cost decision. The following table compares the total estimated costs across all three major premarket pathways.

Cost Category	510(k)	De Novo	PMA
User fee (standard / SB)	$26,067 / $6,517	$173,782 / $43,446	$579,272 / $144,818
Testing	$10K - $150K	$50K - $300K	$100K - $1M+
Clinical data	$0 - $150K	$50K - $500K	$500K - $5M+
Consulting / preparation	$15K - $80K	$50K - $150K	$100K - $300K
Annual reporting	None	None	PMA annual report ($10K-$30K/yr)
Post-market studies	Rarely required	Often required	Almost always required
Typical total (Year 1)	$30K - $500K	$275K - $1M	$1.3M - $7M+
Timeline	3-6 months	6-12 months	12-36+ months

Bottom line: If your device qualifies for the 510(k) pathway — meaning a valid predicate exists and you can demonstrate substantial equivalence — it is almost always the most cost-effective option. Do not pursue a De Novo or PMA unless your device genuinely requires it.

Timeline Impact on Budget

Longer review timelines directly increase costs. Every additional month your submission is under review means another month of consultant fees, personnel costs, and delayed revenue.

Typical 510(k) Timeline and Cost Progression

Phase	Duration	Cost Impact
Preparation and testing	3-9 months	Testing fees, consultant fees, personnel costs
Submission and FDA acceptance review	1-2 months	Minimal additional cost
FDA substantive review (MDUFA goal: 90 days)	3-5 months	Potential additional testing if FDA requests
Additional information (AI) request	+30-60 days	Consultant time, additional testing or documentation
Clearance and post-market setup	1-3 months	Registration, UDI, labeling finalization

How Delays Increase Costs

Delay Scenario	Additional Cost
AI letter response (30-day extension)	$5,000 - $15,000 in consulting fees
Re-testing requested by FDA	$10,000 - $50,000+
Refuse to Accept (resubmission)	$0 (no new user fee within 1 year) + $5,000 - $20,000 in preparation
Not Substantially Equivalent (new submission)	$26,067 new user fee + $20,000 - $80,000 in revised submission

Critical point: A well-prepared first submission is the single most effective cost-saving measure. The difference between a clean first-pass clearance and an NSE determination followed by a new submission can be $50,000-$150,000 and 6-12 months.

Budget Planning Checklist

Use this checklist to build a complete 510(k) budget. Check each item and assign a dollar estimate.

Pre-Submission Phase

• FDA user fee ($26,067 standard or $6,517 small business)
• Small Business Determination application (if applicable — no fee, but allow 60 days)
• Predicate device research and selection ($0 if internal, $3,000-$8,000 if outsourced)
• Testing plan development ($2,000-$5,000)
• Test sample manufacturing ($2,000-$20,000)

Testing Phase

• Biocompatibility testing ($5,000 - $50,000)
• Performance / bench testing ($2,000 - $100,000)
• Electrical safety and EMC ($10,000 - $30,000, if powered)
• Software documentation and verification ($5,000 - $40,000, if applicable)
• Sterilization validation ($8,000 - $35,000, if applicable)
• Packaging validation ($8,000 - $20,000, if applicable)
• Usability testing ($3,000 - $15,000)
• Clinical data / literature review ($0 - $150,000+)

Submission Phase

• Regulatory consulting / submission preparation ($18,000 - $80,000)
• Pre-submission meeting preparation ($5,000 - $15,000, if applicable)
• Labeling and UDI setup ($5,000 - $15,000)
• Establishment registration ($11,423)

Post-Clearance Phase

• US Agent designation ($1,500 - $5,000/year, foreign manufacturers only)
• Post-market surveillance system ($5,000 - $30,000)
• Quality system updates ($5,000 - $15,000)
• Distribution and commercialization setup (varies)

Ongoing Annual Costs

• Establishment registration ($11,423/year, projected to increase)
• US Agent fees ($1,500 - $5,000/year)
• Post-market reporting and surveillance ($5,000 - $20,000/year)

Frequently Asked Questions

Can I get a refund on the 510(k) user fee if my submission is not cleared?

No. The FDA does not refund user fees regardless of the outcome. This includes RTA designations, NSE determinations, and voluntary withdrawals. The fee covers the cost of review, not the outcome. However, if you receive an RTA and resubmit within 12 months with the same device, you do not need to pay a new user fee.

Is the small business fee automatically applied?

No. You must apply for and receive a Small Business Determination (SBD) from the FDA before submitting your 510(k). The SBD application requires your most recent federal tax return and documentation for all affiliates. Processing takes 30-60 days. Plan ahead — the FDA will not retroactively apply the small business rate.

Do I need to pay the establishment registration fee every year?

Yes. The establishment registration fee is an annual fee due between October 1 and December 31. Every establishment that manufactures, prepares, propagates, compounds, or processes a medical device must register and pay this fee. There is no small business reduction for this fee. For FY 2026, it is $11,423 per establishment — a 23% increase from FY 2025.

What is the cheapest way to get a 510(k) cleared?

For eligible devices, the most cost-effective approach is: (1) qualify for small business status to reduce the user fee from $26,067 to $6,517; (2) use the Third-Party Review Program to eliminate the user fee entirely; (3) use eSTAR format to reduce preparation errors; (4) perform as much testing and documentation in-house as your expertise allows; and (5) engage a consultant for strategic review rather than full-service preparation. A small business using third-party review on a low-complexity device could potentially clear for under $30,000 total.

How much should I budget for testing?

Testing costs range from $5,000 for the simplest non-powered, non-contacting devices to over $150,000 for complex implantable or powered devices requiring extensive biocompatibility, EMC, and performance testing. The single best way to control testing costs is to develop a comprehensive test plan early, based on applicable FDA guidance documents and recognized consensus standards, before you commit to a testing laboratory.

Should I use a third-party review organization?

It depends on your device and timeline. Third-party review eliminates the 510(k) user fee ($26,067 saved) and typically results in faster review times. However, the third-party organization charges its own fee ($20,000-$50,000), and not all device types are eligible. If your device is Class II, non-implantable, and qualifies for the program, it is worth serious consideration — especially for small businesses where the fee savings represent a meaningful reduction in total cost.

---

Key Takeaways

1. The FDA user fee ($26,067 standard, $6,517 small business) is just the beginning. Total 510(k) costs range from $30,000 for simple devices to over $500,000 for complex ones
2. Testing is the largest variable cost. Invest in a well-designed test plan before committing to laboratory work
3. The FY 2026 establishment registration fee jumped 23% to $11,423 and is an annual recurring cost with no small business reduction
4. Small businesses can save significantly through the SBD program, third-party review, and fee waivers
5. Hidden costs add up. US Agent fees, UDI setup, post-market systems, and annual registration can add $30,000-$90,000 in Year 1
6. A well-prepared first submission saves more money than anything else. RTAs and NSEs are expensive — invest in quality preparation up front