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Our directory includes FDA 510k consultants and FDA medical device consultants specializing in 510(k) submissions, regulatory strategy, and quality systems. Whether you need a FDA 510k consultant for your medical device submission or ongoing regulatory support, you'll find experienced professionals here. Browse verified FDA medical device consultants to find the right match for your project.
Our directory includes both consulting firms and independent FDA 510k consultants, allowing you to compare options based on your needs and budget. Whether you're looking for a FDA medical device consultant for a 510(k) submission or regulatory strategy guidance, you'll find qualified professionals in our directory.
A 510k consultant (also called a FDA 510k consultant or FDA medical device consultant) is a regulatory affairs professional who specializes in helping medical device companies navigate the FDA 510(k) premarket notification process. These experts guide you through device classification, predicate selection, evidence planning, submission drafting, and FDA communications.
A 510k consultant handles regulatory strategy, device classification, predicate device identification, substantial equivalence analysis, submission document drafting, evidence organization, eSTAR preparation, and FDA communication management. They ensure your submission meets FDA requirements and avoid common pitfalls that lead to RTA (Refuse to Accept) letters or Additional Information (AI) requests.
You should hire a 510k consultant when: your device is novel or borderline De Novo, it's software-heavy or higher-risk, your team has no prior FDA experience, there's uncertainty about classification or predicates, a critical business milestone depends on timely clearance, or you need help with complex clinical strategy or FDA negotiations.
Look for: clear examples of 510(k) clearances in your device category, recent experience with eSTAR submissions, transparent pricing and scope, named experts (not just "team"), willingness to put deliverables in writing, and a clear plan for collaboration. Avoid consultants who promise specific FDA outcomes or can't explain their recent work.
Typical 510k consultant pricing varies by experience level and engagement model:
Price drivers include device complexity, software requirements, multiple device variants, unclear predicates, need for clinical data interpretation, and scope of work (strategy-only vs full drafting vs ongoing FDA management).
Understanding the different types of FDA 510k consultants and FDA medical device consultants helps you find the right expertise for your specific needs.
FDA 510k consultants specializing in 510(k) submissions help with device classification, predicate selection, substantial equivalence analysis, and eSTAR preparation. These FDA medical device consultants are essential for companies navigating their first FDA submission or dealing with complex device categories.
FDA medical device consultants focused on quality systems help implement and maintain FDA-compliant quality management systems (QMS), prepare for FDA inspections, and ensure ongoing regulatory compliance. These professionals are critical for companies maintaining FDA clearance.
FDA 510k consultants provide high-level strategic guidance on regulatory pathways, FDA communication strategies, and long-term regulatory planning. These advisors help companies make informed decisions about their regulatory approach.
Former FDA reviewers bring insider knowledge of FDA review processes, expectations, and communication styles. These FDA medical device consultants often work at consulting firms and provide unique insights into FDA decision-making.
While the terms are often used interchangeably, understanding the distinction helps you find the right FDA 510k consultant or FDA medical device consultant for your needs.
A FDA 510k consultant specializes specifically in 510(k) premarket notification submissions. These professionals help with:
FDA 510k consultants work at consulting firms or independently, providing specialized expertise in the 510(k) pathway.
A FDA medical device consultant provides broader regulatory support across multiple pathways and compliance areas. These professionals typically help with:
FDA medical device consultants offer comprehensive regulatory support for companies at various stages of the medical device lifecycle.
If you're preparing your first 510(k) submission, you need a FDA 510k consultant with submission experience. If you need broader regulatory support across multiple pathways or compliance areas, a FDA medical device consultant is the right choice. Many consulting firms offer both services, and some professionals provide both specialized 510(k) support and comprehensive regulatory guidance. Browse our directory to find FDA 510k consultants and FDA medical device consultants who match your specific needs.
Selecting the right FDA regulatory consulting firm or FDA consultant is critical to your success. Here's a comprehensive guide to evaluating FDA consulting firms.
When evaluating FDA regulatory consulting firms, look for:
Good FDA consulting firms are transparent about:
FDA regulatory consulting firms offer different engagement models:
Common with solo FDA consultants. Pay for time spent, typically $150-$300/hour.
Common with FDA consulting firms. Predictable costs, typically $30k-$80k+ for full submissions.
Ongoing support from FDA regulatory consulting firms. Monthly retainer for advisory services.
When evaluating FDA regulatory consulting firms, avoid:
Use our directory to compare FDA regulatory consulting firms and FDA consultants side-by-side. Filter by device type, pathway, budget, and region to find the right FDA consultant or FDA compliance consultant for your project.
Looking for a FDA consultant near me? Browse FDA consultants and FDA compliance consultants by location to find local FDA regulatory consulting firms.
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Browse California FDA consultants →Find FDA regulatory consulting firms and FDA consultants in Massachusetts, including Boston and Cambridge.
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Browse North Carolina FDA consultants →Many FDA regulatory consulting firms and FDA consultants work remotely and serve clients nationwide.
Browse all FDA consultants →Use our directory filters to find FDA consultants near me by location, or browse FDA regulatory consulting firms that work with clients remotely. All FDA consultants and FDA compliance consultants in our directory are verified and actively serving medical device companies.
Use these 20 essential questions to vet potential 510k consultants and find one who truly understands your device and can navigate the FDA process effectively.
Recent experience is crucial—FDA expectations change. Listen for a specific number, not vague answers like "dozens."
General experience isn't enough—you need someone familiar with your specific device type and product code.
Avoid the "bait and switch"—know the experience level of your actual project lead, not just the salesperson.
Critical for avoiding scope creep and surprise bills. Get a detailed Statement of Work (SOW) in writing.
You need editable source files (Word, Excel), not just final PDFs. This is your intellectual property.
Set realistic expectations. A good consultant provides a phased timeline with clear dependencies.
AI requests are common (70-80% of submissions). Ask if response work is included in the initial fee.
Understand total cost and payment schedule. Fixed fee vs hourly vs retainer—each has pros and cons.
The answer must be "you." This is non-negotiable. Get it in writing in the contract.
You should be able to use your 510(k) content for product updates, international registrations, and QMS docs.
Questions 11-20: What happens if scope changes? How do you handle delays? What's your communication process? Do you have liability insurance? And more.
For full explanations, negotiation tips, red-flag answers, and follow-up questions for each of the 20 questions, download our comprehensive 510k Consultant Engagement Guide (PDF).
download Get the Complete Guide with All 20 QuestionsLearn how to select, scope, contract, and manage a 510k consultant—before you sign anything.
40+ pages of actionable guidance • No email required
Based on structured data from thousands of 510(k) clearances, here are a few patterns that matter when you choose consulting vs software vs hybrid approaches.
Methodology: Based on analysis of 2,143 510(k) clearances from 2019–2024, focusing on preparation time, AI request patterns, and review outcomes.
Software-only devices often spend 3–6 months in preparation before submission, especially when evidence planning starts late. Structured workflows can reduce this by 40–60%.
Submissions with clearly structured test matrices and consistent indications are 35% less likely to get avoidable AI requests. Structured content also reduces review time by an average of 15 days.
Complex indications, clinical strategy, negotiation with FDA, and handling novel technologies. For standard devices with clear predicates, structured software workflows often provide better consistency.
Looking for a 510k consultant? Compare 30+ firms in our directory.
Choosing the wrong 510(k) consultant can waste months and tens of thousands of dollars. Use this checklist to quickly screen advisors before you sign.
For a deep, step-by-step checklist, see our full 510(k) Consultant Engagement Guide .
Download Full Guide (PDF)Honest comparison of your real options – not just "why we're best".
| Hybrid: AI-Structured Workflow + Expert Review | Traditional 510(k) Consultant | DIY With No Specialized Tools | |
|---|---|---|---|
| Who it's best for | Startups and growth-stage companies wanting structured drafts and predictability, plus human judgment where it matters | Teams with budget who want a human to handle nearly everything, but may face opaque pricing and inconsistent structure | Very simple, low-risk devices where cost is the only priority and team has significant time |
| Typical budget range | $5k–$20k (software + targeted review) | $20k–$80k+ (full-service consulting) | $0–$5k (your time + testing costs) |
| Time to first full draft | 2–4 weeks (structured workflow) | 6–12 weeks (depends on consultant capacity) | 3–6 months (learning curve + manual work) |
| How structured the content is | Highly structured, consistent format | Varies by consultant (often less structured) | Manual, inconsistent (unless you're very experienced) |
| Reliance on a single person vs repeatable workflow | Repeatable workflow, consultant adds strategic review | Heavy reliance on consultant availability | Your team's time and expertise |
| Ability to reuse content for future submissions | High (structured templates and workflows) | Low to medium (depends on consultant's approach) | Medium (if you document your process well) |
| Level of internal effort required | Medium (device info input + evidence upload) | Low (consultant handles most) | Very high (you do everything) |
Cruxi is one example of a hybrid AI-structured workflow plus expert review.
If you're leaning toward a structured software-first approach, you can also review our step-by-step 510(k) submission software workflow.
Use this as a quick gut-check before you start emailing 510k consultant firms. In many cases you need a consultant – but not always, and not always for the entire journey.
If you are not sure which bucket you are in, lean toward "moderate" and plan for at least a scoping call with one or two consultants.
You can browse the consultant directory above to identify consultants that match your complexity and device type, and then use the checklist below when you speak with them.
Once you've decided you need help, the real work is picking the right 510k consultant. Here's a simple process that works well for most teams.
Before you send a single email, write a one-page brief that covers:
Sending this upfront helps good consultants give you realistic proposals and filters out people who don't read carefully.
Use the filters above to find firms that:
On your first 30–45 minute calls, ask concrete questions like:
You can adapt this when contacting firms from the directory:
Subject: 510(k) support for [device name] Hi [Name], We're developing a [short description of device, class, and intended use]. We're planning a 510(k) submission targeting [target date, e.g., "Q4 2025"]. Brief overview: • Stage: [prototype / tested / clinical experience / ready to compile] • Evidence we already have: [bench tests, software V&V, etc.] • Internal capacity: [what your team can do] • Budget range for services (excluding testing): [rough range is fine] Could we schedule a short call to discuss whether we're a good fit and what the scope, timeline, and fees might look like? Best, [Your name] [Title, company]
Sending a clear, concise email like this usually gets you better replies and clearer proposals from serious firms.
As a startup, you care about clarity, cost predictability, and a realistic timeline — not regulatory jargon. Your first 510(k) can feel overwhelming. You need a clear path, predictable costs, and a structured timeline. A hybrid AI + consultant approach gives you:
Cruxi offers this kind of hybrid workflow if you want to try it.
Start Your First 510(k)You've done this before, but you want to move faster and reduce internal RA time. You need tools that help you reuse content, speed up eSTAR conversion, and maintain consistency across submissions. An AI-structured workflow helps you:
Cruxi is one way to implement this type of AI-structured workflow.
Accelerate Your WorkflowAs a consultant, you want to focus on strategy and high-value work, not manual drafting. AI tools can handle the heavy lifting of drafting and evidence mapping, letting you focus on what matters most. Plus, get qualified leads through our consultant directory. Cruxi gives you a structured workspace and leads, instead of a blank page.
AI-structured workflows can help you:
Most consultant engagement disasters are preventable. Here are the biggest mistakes companies make—and how to avoid them.
The cheapest consultant is often the least experienced. This "savings" upfront leads to higher costs later: extra billable hours, mistakes requiring rework, and worst of all, a rejected submission. Compare 3-5 quotes, focus on value over price, and ask about their process.
Warning signs: Quote 50% lower than others, high-pressure sales tactics, vagueness about what's not included.
Experience from 2015 isn't the same as 2024. FDA guidance evolves constantly, especially in areas like cybersecurity, software, and sterilization. A consultant without recent, relevant experience is learning on your dime.
Warning signs: Talks about "decades of experience" but cagey about recent projects, can't provide K-numbers for similar devices from last 2-3 years.
High-level conversations without drilling into specific tasks, responsibilities, and deliverables lead to scope creep, surprise invoices, and project conflict. Create a responsibility matrix before signing anything.
Warning signs: Proposals using vague language like "assist" or "support" without definitions, reluctance to create detailed task lists.
A contract with a vague, one-paragraph description is a recipe for disaster. The SOW must explicitly list every task, deliverable, and exclusion. Attach your responsibility matrix as an official exhibit to the contract.
Warning signs: One-sentence SOW, consultant pushes back on adding detailed task lists saying "it's too restrictive."
If the contract doesn't specify ownership, a consultant could argue the documents are their property. Insist on a "Work for Hire" clause stating all work products are your sole and exclusive property. This is non-negotiable.
Warning signs: No IP section in contract, language like "Client has a license to use" (implies they retain ownership).
A polished proposal can hide project management sins. Always call 2-3 references from similar projects in the last 18 months. Ask about communication, deadlines, and how they handled problems.
Warning signs: Hesitation to provide references, only old references (5+ years), references seem coached.
A lack of communication is a major source of project failure. Establish response time commitments, meeting frequency, and status update schedules upfront. Vague promises like "we're always available" are red flags.
Warning signs: No structured update process, vague communication promises, no escalation point defined.
Want the full details? Our comprehensive guide includes real-world examples, step-by-step prevention strategies, and warning signs for each pitfall.
download Download the Complete Pitfalls Guide (PDF)Short, practical answers to the questions teams ask most often when they're deciding whether and how to work with a 510(k) consultant.
An FDA consultant (also called a 510k consultant or FDA compliance consultant) is a regulatory affairs professional who specializes in helping medical device companies navigate FDA regulatory processes, including 510(k) premarket notifications. They guide you through device classification, predicate selection, evidence planning, submission drafting, and FDA communications. FDA consultants work at FDA regulatory consulting firms or as independent FDA advisors.
To find FDA compliance consultants, start by browsing directories like this one that list FDA regulatory consulting firms and individual FDA consultants. Filter by your device type, regulatory pathway, and budget. Look for FDA compliance consultants with experience in your specific device category and recent FDA submission success. Many FDA consulting firms offer free consultations to discuss your project needs.
FDA regulatory consulting firms provide comprehensive regulatory support for medical device companies. They offer services including FDA submission preparation (510(k), De Novo, PMA), device classification, predicate device research, regulatory strategy, quality system consulting, and FDA communication management. FDA consulting firms typically have teams of FDA consultants with diverse expertise across different device categories and regulatory pathways.
FDA consultants typically charge $150-$300 per hour for solo consultants, while FDA consulting firms often offer fixed-fee packages ranging from $15k-$80k+ for full 510(k) submission support. FDA compliance consultants may charge differently based on scope (strategy-only vs. full drafting). Factors affecting FDA consultant pricing include device complexity, software requirements, and project scope. Many FDA regulatory consulting firms provide transparent pricing during initial consultations.
Look for: clear examples of 510(k) clearances in your device category, recent experience with eSTAR submissions, transparent pricing and scope, named experts (not just "team"), willingness to put deliverables in writing, and a clear plan for collaboration. Avoid consultants who promise specific FDA outcomes or can't explain their recent work.
For a complete selection checklist and the top 20 questions to ask: Download our 510k Consultant Engagement Guide (PDF), which includes evaluation frameworks, red flags to watch for, and reference check questions.
A 510k consultant handles regulatory strategy, device classification, predicate device identification, substantial equivalence analysis, submission document drafting, evidence organization, eSTAR preparation, and FDA communication management. They ensure your submission meets FDA requirements and avoid common pitfalls that lead to RTA (Refuse to Accept) letters or Additional Information (AI) requests.
Typical 510k consultant pricing: Solo consultants $15k–$40k (often hourly, $150–$300/hour), Consulting firms $30k–$80k+ (fixed-fee or retainer-based), Law firms $50k–$150k+ (premium pricing), CRO/Full-service $40k–$100k+, Hybrid AI + consultant models $5k–$20k. Price drivers include device complexity, software requirements, multiple device variants, unclear predicates, and scope of work.
A 510(k) consultant typically handles: regulatory strategy (classification, predicate selection, product code identification), drafting submission documents (indications, substantial equivalence, test summaries), coordinating with FDA (pre-sub meetings, responding to AI requests), and ensuring compliance with FDA guidance and regulations.
Day-to-day work includes reviewing your device data, writing regulatory narratives, organizing evidence, preparing eSTAR submissions, and managing FDA communications. Some consultants also help with QMS documentation, risk management files, and labeling.
Most 510(k) consulting projects range from $15k to $80k+ (excluding testing costs). Solo consultants often charge $150–$300/hour, while firms typically offer fixed-fee or retainer arrangements.
Price drivers include: device complexity (novel tech, borderline De Novo), software-heavy devices requiring cybersecurity documentation, multiple device variants or indications, lack of clear predicates, need for clinical data interpretation, and scope of work (strategy-only vs full drafting vs ongoing FDA management).
For detailed pricing breakdowns and negotiation strategies: Our 510k Consultant Engagement Guide includes typical cost ranges by firm type, pricing model comparisons (fixed fee vs time & materials), and tips for negotiating based on your device stage and internal RA capacity.
Preparation time (before FDA submission) typically ranges from 3–6 months with a full-service consultant, depending on evidence readiness, device complexity, and consultant availability.
Factors that extend timelines: incomplete evidence (bench tests, software V&V), unclear predicates requiring extensive research, multiple FDA rounds of Additional Information (AI) requests, and consultant workload/availability. Once submitted, FDA review is typically 90 calendar days, but can extend with AI requests.
Watch for: vague answers about device types and product codes they've handled, no recent 510(k) examples (only generic "regulatory experience"), unwillingness to put scope and deliverables in writing, promising specific FDA outcomes ("we guarantee clearance by X date"), and no clear plan for collaboration (who writes what, who owns documents).
Also be cautious of consultants who can't explain their eSTAR experience, don't have recent clearances in your device category, or seem unwilling to discuss how they handle FDA AI requests.
No. No consultant can legally guarantee FDA clearance. The FDA makes the final decision based on your device's safety and effectiveness data, substantial equivalence demonstration, and compliance with regulations.
A good consultant can significantly improve your chances by: ensuring proper classification, selecting appropriate predicates, structuring evidence clearly, avoiding common submission pitfalls, and managing FDA communications effectively. But they cannot guarantee outcomes, and any consultant who promises specific clearance dates or outcomes should be avoided.
DIY can work for: simple Class I or II devices with very clear predicates, teams with experienced in-house RA professionals who've done multiple submissions, low-risk devices with well-documented regulatory pathways, and situations where cost is the only priority and you have significant internal time.
You should hire a consultant when: the device is novel or borderline De Novo, it's software-heavy or higher-risk, your team has no prior FDA experience, there's uncertainty about classification or predicates, a critical business milestone depends on timely clearance, or you need help with complex clinical strategy or FDA negotiations.
Cruxi is an AI-powered platform that structures your 510(k) submission workflow. It's designed to work alongside consultants, not replace them.
In a hybrid model, Cruxi handles the structured drafting, evidence mapping, and content consistency, while your consultant focuses on regulatory strategy, FDA interactions, and high-level review. This can reduce costs (less consultant time on basic drafting) and speed up preparation (structured workflows are faster than manual document creation). You can use Cruxi on your own first, then add consultant review when ready, or start with both from the beginning.
In short: define deliverables per section, review cycles, timelines, and responsibilities on both sides. The Statement of Work (SOW) must explicitly list every task, deliverable, and exclusion. Attach a responsibility matrix as an official exhibit to the contract.
For complete contract guidance: Our 510k Consultant Engagement Guide includes a sample SOW outline, a checklist of essential clauses (IP ownership, confidentiality, change control, termination), and real-world examples of what to include and exclude.
Use a structured, AI-supported workflow to organize your submission, then choose the right level of human support from our expert network.
