How to Prepare Your First FDA Submission: Step-by-Step Guide 2025
- Beng Ee Lim
- 2 days ago
- 9 min read
Preparing your first FDA submission involves five critical steps: classify your device accurately, determine the appropriate regulatory pathway (510(k), De Novo, or PMA), gather required technical and clinical documentation, consider engaging FDA through a Pre-Submission meeting, and submit through FDA's electronic systems with proper formatting and user fees.
This guide provides practical, step-by-step preparation strategies specifically for startup founders navigating their first FDA submission.
Understanding What You're Getting Into
Your first FDA submission feels overwhelming because it genuinely is complex. Unlike launching software or consumer products, medical devices require regulatory clearance before you can legally market them in the United States.
The good news: FDA provides clear pathways and support programs specifically designed to help innovators.
The challenge: knowing which pathway applies to your device and what FDA expects to see in your submission.
Reality Check for Founders
Many founders underestimate how long preparation takes — often by 3–6 months or more. For a moderately complex device (especially if clinical data are required), plan 6 to 12 months (or more) just for the submission build. Be cautious — this does not include full device development or iterative cycles.
Step 1: Classify Your Device Accurately
Device classification determines everything else about your regulatory journey. Getting this wrong wastes months of work on the wrong pathway.
The Three Device Classes
Class I (Low Risk)
Examples: elastic bandages, manual surgical instruments, tongue depressors.
These devices pose minimal patient risk. Most Class I devices are exempt from premarket submission requirements, though you still need establishment registration and device listing.
Class II (Moderate Risk)
Examples: powered wheelchairs, infusion pumps, surgical drapes.
These devices require general controls plus special controls to provide reasonable assurance of safety and effectiveness. Most Class II devices require 510(k) clearance.
Class III (High Risk)
Examples: heart valves, implantable pacemakers, breast implants.
These devices support or sustain life, are implanted, or present potential unreasonable risk of illness or injury. Class III devices typically require Premarket Approval (PMA).
How to Find Your Classification
Use FDA's Product Classification Database to search by device type or intended use. The classification regulation includes the device class and whether a premarket submission is required.
If no applicable classification exists, or it’s ambiguous, you can submit a 513(g) Request for Information for FDA’s classification opinion.
The user fee for a 513(g) in FY 2025 is $7,301, or $3,650 for a certified small business.
513(g) provides nonbinding classification feedback, not clearance or approval.
FDA aims to respond within ~60 days (though real times may vary).
Step 2: Select Your Regulatory Pathway
Classification suggests the appropriate regulatory pathway, but you have options depending on your device characteristics.
Best for: Class II devices and some Class I devices with predicates
Timeline: 90 days FDA review (often longer with questions)
Strategy: Demonstrate substantial equivalence to a legally marketed predicate device
The 510(k) pathway is most common for startups. You're not proving your device is safe and effective from scratch—you're proving it's substantially equivalent to something already on the market.
This step often takes hours of manual digging through the 510(k) database. Complizen’s Predicate Intelligence automates that search — surfacing recent, similar clearances and their testing summaries so you can see what worked for others in your space.
Key 510(k) Success Factors:
Choose your predicate device carefully (legally marketed, not recalled)
Clearly demonstrate substantial equivalence in intended use and technological characteristics
Address any differences with performance data
Best for: Novel low-to-moderate risk devices without predicates
Timeline: 150 days FDA review after acceptance
Strategy: Demonstrate device safety and effectiveness through general and special controls
De Novo has become increasingly attractive for startups, especially after 2021 regulatory updates. Successfully classified De Novo devices become predicates for future 510(k) submissions, potentially creating competitive moats.
Strategic Advantage: If you're first-to-market with a novel technology, De Novo classification lets you define the special controls, creating regulatory barriers for competitors.
Best for: Class III devices
Timeline: 180 days FDA review (plus potential panel meetings)
Strategy: Provide valid scientific evidence of safety and effectiveness
PMA is the most stringent pathway, requiring comprehensive clinical trial data. Few startups pursue PMA for first products due to timeline and cost implications, but some therapeutic device companies have no choice.
Best for: Devices treating rare conditions (fewer than 8,000 patients annually in US)
Timeline: 75 days FDA review
Strategy: Demonstrate device probably benefits patients versus risk
HDE provides an alternative for devices addressing rare diseases where conducting clinical trials would be impractical.
Step 3: The Pre-Submission Strategy
The Pre-Submission (Pre-Sub or Q-Sub) is one of FDA's most valuable programs for startups, yet many founders skip it or use it incorrectly.
What Is a Pre-Submission?
A formal mechanism to obtain FDA feedback before submitting your actual marketing application. You ask specific questions, and FDA provides written responses or meets with you to discuss your regulatory strategy.
When to Submit a Pre-Sub
Ideal timing: 6-12 months before your planned marketing submission. You need enough development progress to ask informed questions, but early enough to incorporate FDA feedback without major pivots.
Submit your request electronically
FDA reviews and schedules meeting within 60-75 days
Meeting occurs (typically 1 hour via teleconference)
FDA provides written meeting minutes within 30 days
What to Ask in Your Pre-Sub: Focus on specific questions where FDA's answer will guide your development:
Good Pre-Sub Questions:
"Is our proposed predicate device acceptable for substantial equivalence comparison?"
"Is our clinical study design adequate to support our intended use claims?"
"Are our proposed biocompatibility tests sufficient given our device materials and contact duration?"
Poor Pre-Sub Questions:
"What is the classification of our device?" (Use 513(g) instead, or research yourself)
"Can you review our draft 510(k)?" (FDA doesn't pre-review submissions)
"Do we need clinical data?" (Too vague—be specific about your device and intended use)
Cost Considerations
Pre-Submissions are free — one of the few FDA tools with no user fee.
In contrast, a 513(g) classification request costs $7,301 standard or $3,650 for certified small businesses in FY 2025.
The small business 510(k) user fee in FY 2025 is $6,517 (versus ~$26,067 standard).
Because there’s no fee, Pre-Subs are a high-ROI strategy — especially for novel or borderline devices. But preparation is key: vague or poorly scoped Pre-Subs may be rejected or yield limited value.
Step 4: Assemble Your Submission Team
Internal Team Roles
Regulatory Lead: Your regulatory point person owns FDA communication and submission strategy. For first-time founders, this is often you or your VP of Regulatory Affairs if you've hired one.
Technical Lead: Someone who deeply understands your device technology and can articulate design rationale, performance testing, and risk mitigation.
Clinical Lead: If clinical data is required, you need someone experienced in clinical study design and execution.
Quality/Manufacturing Lead: Responsible for demonstrating your manufacturing processes produce consistent, safe devices.
External Resources to Consider
Regulatory Consultants: Experienced consultants accelerate your submission preparation and help avoid costly mistakes. Good consultants have submitted dozens of devices similar to yours and know FDA reviewers' expectations.
When to Hire Consultants:
Your device is novel or high-risk
You lack internal regulatory expertise
You need to accelerate timeline
You want to maximize first-submission success probability
Testing Laboratories: You'll need accredited labs for performance testing, biocompatibility, electrical safety, EMC, and other testing depending on your device.
Clinical Research Organizations (CROs): If you need clinical data, CROs manage study execution, data collection, and regulatory reporting.
Step 6: Format and Submit Electronically
Electronic Submission Requirements
FDA requires electronic submissions through either:
eCopy: Electronic copy of a paper submission—essentially a scanned PDF version with proper formatting and organization.
eSTAR (Electronic Submission Template and Resource): Structured PDF template that guides you through required sections. FDA prefers eSTAR for 510(k) submissions.
CDRH Portal Account: Create an account at FDA's CDRH Portal to submit electronically and track your submission status.
User Fees
510(k) Fees (FY 2025):
Standard: $26,027
Small Business: $6,517
PMA Fees (FY 2025):
Standard: $457,939
Small Business: $114,485
Always verify current fees before submitting. (FDA MDUFA Fees)
Small Business Qualification Companies with gross receipts or sales under $200 million qualify for reduced fees. Submit Form 3602A to request small business determination.
Step 7: What Happens After Submission
FDA Acceptance Review: FDA conducts administrative review within 15 days. They check completeness and proper formatting. If issues exist, FDA issues a Refuse to Accept (RTA) letter giving you 30 days to correct deficiencies.
Substantive Review: Once accepted, FDA begins substantive technical review. Review timelines:
510(k): 90 days (often 120+ with Additional Information requests)
De Novo: 150 days
PMA: 180 days (plus potential Advisory Panel meetings)
Additional Information Requests: FDA often requests additional information or clarification. Respond quickly and completely—delays here extend your review timeline significantly.
Potential Outcomes
510(k) Clearance: FDA issues clearance letter stating your device is substantially equivalent to the predicate.
De Novo Grant: FDA grants your De Novo request and establishes your device as Class I or II with applicable special controls.
PMA Approval: FDA approves your PMA, allowing you to market your device for approved indications.
Not Substantially Equivalent (NSE): For 510(k)s, FDA may determine your device is not substantially equivalent, requiring you to pursue De Novo or PMA pathways.
Common Founder Mistakes to Avoid
Starting Too Late Founders often treat FDA submission as the last step before launch. In reality, regulatory strategy should inform product development from day one. Design choices affect testing requirements, clinical needs, and ultimate timeline.
Choosing Wrong Predicate Selecting a recalled device, device no longer marketed, or poor technological match as your predicate wastes months. Research predicates thoroughly using FDA's 510(k) database.
Underestimating Testing Requirements Performance testing takes longer and costs more than founders expect. Plan 3-6 months for comprehensive testing depending on device complexity.
Skipping Pre-Submission The Pre-Sub is free and can save you from expensive mistakes. Use it, especially if your device is novel or if you're uncertain about FDA's expectations.
Poor Documentation Quality Incomplete, poorly organized, or inadequately referenced submissions generate endless FDA questions. Invest time in clear, comprehensive documentation upfront.
Inadequate Budget Planning First-time founders routinely underbudget submissions by 50-100%. Include testing costs, consultant fees, user fees, and contingency for additional testing FDA may request.
Treating research and documentation as separate steps: In reality, they inform each other. Complizen helps unify your findings, so classification, predicates, and tests stay aligned throughout your submission prep.
Timeline and Budget Planning
Realistic Timeline for First Submission
Pre-Submission Phase (2-4 months)
Device classification research
Predicate identification
Pre-Sub preparation and meeting
Testing and Documentation (4-8 months)
Performance testing
Clinical studies (if required)
Document preparation
Technical writing and review
Once your predicate is chosen, the next challenge is knowing which tests and standards apply. Complizen’s Tests & Standards module cross-references FDA-recognized standards used in similar devices — helping you plan your validation strategy more confidently.
Submission and Review (3-6 months)
Submission formatting and quality check
FDA review period
Additional Information responses
Total: 9-18 months from project start to clearance
Using Complizen’s Strategy Draft tool, you can compile all findings — predicates, tests, risks — into a defensible draft strategy that aligns with FDA expectations.
Internal Costs:
Staff time for documentation and coordination
Manufacturing samples for testing
External Costs:
Testing laboratory fees: $50,000-$150,000+
Clinical studies: $100,000-$500,000+ (if required)
Regulatory consultants: $50,000-$200,000+
FDA user fees: $13,864-$27,729 (510(k))
Total Budget Range: $150,000-$500,000+ for typical startup 510(k)
Many of these costs come from the time spent on repetitive regulatory research. Automating that phase with Complizen helps reduce consultant dependence and brings your submission timeline closer to the lower end of that range.
Leveraging FDA Support Programs
For devices treating life-threatening or irreversibly debilitating conditions, this voluntary program provides:
More frequent FDA interaction
Priority review
Potential expedited pathways
Pilot program promoting early, strategic communications between FDA and device sponsors for innovative devices.
Small Business Programs
FDA offers resources specifically for small businesses including reduced user fees and dedicated support through Division of Industry and Consumer Education (DICE).
Preparing your first FDA submission doesn’t have to feel impossible. The right structure — and the right tools — can turn this from a 12-month slog into a clear, guided process.
Complizen helps startups and consultants build defensible regulatory strategies in minutes, backed by FDA sources.
👉 Start free or book a quick walkthrough at complizen.ai
The Fastest Path to Market
No more guesswork. Move from research to a defendable FDA strategy, faster. Backed by FDA sources. Teams report 12 hours saved weekly.
FDA Product Code Finder, find your code in minutes.
510(k) Predicate Intelligence, see likely predicates with 510(k) links.
Risk and Recalls, scan MAUDE and recall patterns.
FDA Tests and Standards, map required tests from your code.
Regulatory Strategy Workspace, pull it into a defendable plan.
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Frequently Asked Questions
Do I need to hire a regulatory consultant for my first submission?
Not required, but experienced consultants significantly increase success probability and reduce timeline. Consider consultants if your device is novel, high-risk, or if you lack regulatory expertise.
How do I know if I need clinical data?
Device classification regulation indicates clinical data requirements. Generally required for novel devices, high-risk devices, or when performance testing alone cannot demonstrate safety and effectiveness. Use Pre-Sub to discuss with FDA.
Can I make changes to my device during FDA review?
Minor clarifications are acceptable, but design changes during review complicate the process. FDA may require you to withdraw and resubmit with updated information.
What if FDA says my device is Not Substantially Equivalent?
You can pursue De Novo pathway if your device is low-to-moderate risk, or PMA pathway if it's high risk. You can also identify a different predicate and resubmit.
How long does FDA clearance last?
510(k) clearance doesn't expire, but you must maintain compliance with Quality System Regulation and report changes that could affect safety or effectiveness.
Should I submit a Pre-Sub even if I think my pathway is straightforward?
Yes, especially for first submissions. Even straightforward devices benefit from FDA confirming your regulatory strategy and highlighting potential issues early.
