7 Red Flags When Hiring an FDA 510k Consultant
Hiring a 510k consultant can be one of the best investments you make—or it can go spectacularly wrong. A bad consultant relationship can lead to blown budgets, missed deadlines, FDA rejections, and immense frustration. Here are the warning signs to watch for.
warning Red Flag #1: "Guaranteed Clearance"
What it is: A consultant promises specific FDA outcomes, like "We guarantee clearance in 90 days" or "We have a 99% success rate."
Why it's a problem: No one can guarantee an FDA clearance. The process is interactive and unpredictable. A reputable consultant will talk about maximizing your chances and efficiently navigating the process, not about guarantees.
Real-world consequence: A startup hired a consultant who promised "guaranteed clearance by Q2." When the FDA issued an Additional Information request (which is normal), the consultant blamed the FDA and the client, refused to help with the response, and the project stalled. The startup had to hire a new consultant mid-project.
- Promises specific clearance dates
- Claims unrealistic success rates (99%+)
- Blames past failures on "bad clients" or "unreasonable FDA"
warning Red Flag #2: Vague or Opaque Pricing
What it is: You can't get a clear idea of their fee structure from their website or initial contact. They're evasive about what's included vs excluded.
Why it's a problem: Hidden fees and "scope creep" are common problems. If they won't be transparent about pricing upfront, you're setting yourself up for surprise bills later.
Real-world consequence: A company received a quote for "$50k for the 510(k)." Three months in, they got invoices for "FDA communication management" ($8k), "document formatting" ($5k), and "AI request response" ($12k), none of which were mentioned in the original quote. The final cost was $75k, not $50k.
- Unwillingness to provide a written proposal with line items
- Vague answers like "we'll figure it out as we go"
- Resistance to defining what's excluded from the fee
warning Red Flag #3: No Specific Examples
What it is: A consultant only talks in generalities ("we have a lot of experience," "we have a high success rate") but can't provide specific, anonymized examples of devices similar to yours.
Why it's a problem: They may be exaggerating their expertise. A consultant familiar with your device type will be able to discuss specific challenges, guidance documents, and strategies.
Real-world consequence: A company developing a wearable ECG monitor hired a consultant who claimed "extensive cardiovascular device experience." When asked for specific examples, they provided only one case—a simple blood pressure cuff from 2018. The consultant wasn't familiar with modern cybersecurity requirements for connected devices, leading to a rejected submission.
- Can't provide K-numbers (510(k) clearance numbers) for similar devices
- Only talks about "years of experience" without recent examples
- Dismisses your questions about specific device types as "minor details"
warning Red Flag #4: High-Pressure Sales Tactics
What it is: You feel rushed, pressured into signing a contract immediately, or told "this special offer expires today."
Why it's a problem: A good consultant is a partner, not a salesperson. High-pressure tactics are a sign they're more interested in closing the deal than understanding your needs.
Real-world consequence: A startup was pressured into signing a contract "today" with a 50% upfront payment. After signing, the consultant was unresponsive for weeks, missed deadlines, and delivered low-quality work. The startup had already paid half the fee and had little leverage.
- "This price is only valid today"
- Rushing you to sign without time to review the contract
- Making you feel guilty for asking questions or comparing options
warning Red Flag #5: Poor Communication Early On
What it is: Their website is full of typos, they take a week to respond to your initial inquiry, or they're disorganized in early conversations.
Why it's a problem: These early signs of sloppiness and poor communication often predict how they'll handle your project. If they can't respond promptly during the sales phase, they won't improve after you sign.
Real-world consequence: A company noticed multiple typos on the consultant's website but ignored them. After hiring, they discovered the consultant was consistently late with deliverables, sent documents full of errors, and took days to respond to urgent FDA questions. The project suffered multiple delays.
- Typos or grammatical errors on their website or proposals
- Slow response times (more than 48 hours) to initial inquiries
- Disorganized or unclear communication
warning Red Flag #6: Unwillingness to Put Scope in Writing
What it is: The consultant resists creating a detailed Statement of Work (SOW) or responsibility matrix. They prefer vague language like "we'll handle everything."
Why it's a problem: This is the root cause of scope creep and surprise invoices. Without a clear SOW, you'll have disagreements about what's included vs excluded.
Real-world consequence: A dental device company hired a consultant with a one-sentence SOW: "Consultant will prepare the 510(k) submission." Three months in, the consultant sent them a list of 15 documents they needed the company to write, including the full device description and sterilization validation summary. The company assumed the consultant's fee covered writing these sections.
- One-sentence scope descriptions
- Resistance to creating a detailed task list
- Statements like "we're a team, we'll figure it out as we go"
warning Red Flag #7: Refusal to Provide References
What it is: The consultant hesitates or refuses to provide references from recent clients, or only provides references from projects 5+ years old.
Why it's a problem: A reference check is your only real glimpse into what it's actually like to work with them. Skipping this step is like buying a house without an inspection.
Real-world consequence: A diagnostics company hired a consultant who seemed brilliant in initial meetings. They didn't check references. Two months in, they discovered the consultant was a terrible communicator—emails went unanswered for days, deadlines were missed without warning. They later found out from an industry peer that the consultant had a reputation for taking on too many clients and ghosting them.
- Hesitation or refusal to provide references
- Only provides references from old projects (5+ years)
- References seem coached or give vague, one-word answers
How to Avoid These Red Flags
Use a structured vetting process:
- Get 3-5 quotes to establish a realistic market range
- Ask specific questions about their experience with your device type
- Request a detailed SOW with clear deliverables and exclusions
- Check references from similar projects in the last 18 months
- Verify their claims using the FDA's public 510(k) database
Want the Complete Checklist?
Our comprehensive 510k Consultant Engagement Guide includes:
- Top 20 questions to ask before hiring
- Complete evaluation checklist
- Contract clauses to watch for
- Real-world case studies of what goes wrong