How to Find a Great FDA 510(k) Consultant (Even If You’ve Never Done This Before)

If you’re reading this, there’s a good chance you’re in one of these situations: You’ve built (or are building) a medical device or health software, Someone said the words “510(k) submission”, And now your team is googling “FDA 510k consultant” at 11:30 pm. You’re not alone. The problem: There’s no single, trusted directory. Every firm looks “experienced.” Everyone says they’ve “done 510(k)s.” And the stakes are high — the wrong consultant can cost you months of delay and tens of thousands of dollars with nothing to show for it. This guide walks through how to choose a 510(k) consultant, what to ask, where to find them, and how AI tools can actually make the relationship more efficient instead of replacing them. Press enter or click to view image in full size 1. First, be clear on what you actually need “510(k) help” can mean very different things: “We have almost nothing.” No clear intended use, no risk analysis, no testing plan, no draft documents. You need end-to-end regulatory strategy + hands-on writing. “We have a lot of docs, but no structure.” Specs, test reports, internal slide decks, Jira tickets — but nothing in an FDA-ready format. You need someone to organize, gap-analyze, and convert this into 510(k)/eSTAR language. “We’ve done submissions before, but not for this device type.” Your team knows the basics but needs device-specific expertise (e.g., AI/ML software, SaMD, wearables, home use devices, etc.). If you’re not clear on what you need, every consultant call will sound like a generic sales pitch. Before you contact anyone, write down: What your device does (in plain language). Who it’s for (patients, clinicians, home use, hospital use) What you think your primary pathway is (510(k), De Novo, “not sure”). Your timeline and budget range. This alone will make conversations with consultants 10x more productive. 2. What actually matters in a 510(k) consultant Not all “FDA consultants” are the same. Some are excellent in pharma but light on devices. Others are general “quality/regulatory” but rarely lead submissions. For 510(k), here’s what really matters: a) Experience with similar devices Ask very directly: “Have you led 510(k)s for devices similar to ours? Can you give examples (without confidential details) — device type, class, and the general outcome?” You’re looking for: Same category (e.g., cardiology, imaging, software-only, wearable sensors). Similar risk profile and intended use. Recent experience in the last 2–3 years, not just “I did one 15 years ago.” b) Comfort with your technology type Some consultants are brilliant with hardware but light on: Software as a Medical Device (SaMD) AI/ML algorithms Cloud platforms and cybersecurity requirements Mobile apps, home monitoring, wearables If your product is software-heavy, you need someone who is comfortable with: IEC 62304, IEC 82304–1, and software documentation expectations Cybersecurity content (threat models, SBOMs, patching plans) Human factors / usability for apps and connected devices Ask: “What kind of software/AI or cloud-based devices have you worked on recently?” c) Understanding of current FDA expectations Regulation doesn’t stand still. FDA has: Newer guidance documents Updated thinking on clinical evidence eSTAR as the current format for most 510(k)s Ask: “Have you submitted in eSTAR format?” “How do you stay up to date with FDA expectations in our area?” A good consultant will talk about specific guidances, recent trends, and not just “I’ve been in this for 20 years.” d) How they work with your team You’re not just buying expertise; you’re buying a working relationship. Become a member Good signals: They ask many questions about your device and internal capabilities. They’re honest about what’s unclear or risky. They explain things in plain English, not just CFR citations. Ask: “How do you typically work with a startup team like ours? Who does what? What do you expect from us?” 3. Pricing models and red flags Consultants usually structure work like this: Fixed-fee packages for a defined scope (e.g., full traditional 510(k) from strategy to submission). Hourly rates for open-ended advisory work and unexpected issues. Hybrid: a base fee + hourly for extras (e.g., multiple FDA rounds, major scope changes). What you should look for: A clear, written scope — what’s included, what’s not. Who writes which sections (them vs your team). Whether meeting time and FDA meeting prep are included. Red flags: “We guarantee clearance by [date].” No one controls FDA timelines. Very low prices compared to market, with no explanation. 510(k) work is complex. If a quote looks too good to be true, it usually is. Vague answers about experience, or refusal to discuss general examples. 4. Where to find 510(k) consultants There’s no single perfect marketplace, but you can combine several sources: a) Google search (but read beyond the homepage) Search terms like: “FDA 510k consultant” “510k regulatory consultant for [device type]” “medical device regulatory consulting firm 510k” Don’t just click the first ad. Look for: Case studies or anonymized examples. Clarity about device types they focus on. Real content (articles, guides, webinars), not only marketing slogans. b) Professional networks Ask investors, advisors, or other founders in your space: “Who helped you with your 510(k)? Would you work with them again?” Check LinkedIn for people who list: “510(k) submissions” Specific device types Real project descriptions, not just job titles. c) Industry associations & directories Some directories and professional groups list consultants and firms by specialty. These can help you compile a shortlist, then you still do your own filtering and interviews. d) Curated consultant networks Some platforms (including ours at Cruxi) are trying to solve the “messy directory” problem by: Pre-filtering consultants with real device experience Organizing them by pathway (510(k), De Novo, PMA, etc.) and device type Letting you submit one project brief and get matched to multiple consultants If you use a network like this, you still ask the same questions as above — but the initial search is much faster. 5. How AI tools fit in (and how they help you, not replace the consultant) A common misconception is: “If we use AI, we don’t need a consultant.” For most teams, that’s not realistic. The more useful frame is: “How can we use AI to reduce repetitive work and make our consultant’s time more valuable?” Here’s a practical split: AI platforms (like Cruxi) are great at: Structuring device intake Suggesting classification and predicate options Generating evidence/test checklists Drafting sections in 510(k)/eSTAR structure for you to review Consultants are essential for: Final regulatory strategy Deciding intended use / indications Predicate selection and equivalence arguments Handling grey areas, risk trade-offs, and FDA interactions This is why a hybrid model can be powerful: You run your device through an AI-powered workflow. The system helps you organize content, draft sections, and understand what testing/evidence is expected. Then a consultant reviews, corrects, and strengthens everything — focusing on judgment, not formatting or chasing missing bullets. You get: Fewer billable hours spent on basic drafting. Higher quality input for the consultant to refine. Clearer visibility into gaps before you’re deep into FDA questions. 6. Questions to ask before you sign with anyone Here’s a simple checklist you can literally copy into your next email or call: Experience “What types of devices have you supported for 510(k) in the last 2–3 years?” “Have you worked on [software/AI/wearable/home use/etc.] devices like ours?” Process “How do you usually structure a 510(k) project from first call to submission?” “What do you expect from our team, and what do you handle?” Tools “Are you open to working with AI-powered tools to help structure and draft parts of the submission, as long as you remain in control of quality?” Scope & pricing “Can you send a written scope broken down by phases (strategy, drafting, submission, FDA questions)?” “What’s included in the fixed fee vs what’s billed hourly?” Communication “How often do we meet?” “Who will be our day-to-day contact?” If a consultant answers these clearly, asks good questions back, and doesn’t overpromise — that’s a strong sign. 7. Putting it all together Finding the right 510(k) consultant isn’t about hunting for a magical name; it’s about: Knowing what you need Asking the right questions Combining human expertise with modern tools If you’re at the stage where you’re exploring consultants and also curious how AI can reduce the heavy lifting, platforms like Cruxi -FDA 510 (k) Consultants are trying to bridge exactly that gap: AI does the repetitive work; experienced consultants handle the critical decisions. Either way, the earlier you bring structured regulatory thinking into your product, the cheaper and less painful your 510(k) will be. Source: https://medium.com/@cruxiapp/how-to-find-a-great-fda-510-k-consultant-even-if-youve-never-done-this-before-983677af4f0b?postPublishedType=initial