Published: December 2025 | Category: 510(k) Consulting

How to Scope a 510k Consultant Project (Without Getting Burned)

Vague scope discussions are the root cause of scope creep, surprise invoices, and project conflict. Here's how to define a crystal-clear Statement of Work (SOW) that protects both you and your consultant.

Step 1: Create a Responsibility Matrix

Before signing anything, create a simple chart. List every major task and assign responsibility:

Task Consultant Client Shared
Device Classification ✓
Predicate Search & Selection ✓
Write Device Description ✓
Provide Test Reports ✓
Manage Testing Labs ✓
Final Submission Assembly ✓

Go through this line by line with your consultant before signing. This prevents assumptions and misalignments.

Step 2: Define "Help" vs. "Do"

Clarify the verbs. Vague language leads to misunderstandings:

Vague: "Consultant will help with testing."

What this could mean:
  • They recommend a lab (minimal effort)
  • They write the protocol (moderate effort)
  • They manage the lab and interpret results (significant effort)
Clear: "Consultant will review client-provided test protocols and provide feedback. Consultant will NOT manage testing labs, coordinate with labs, or pay for testing. Client is responsible for all testing execution and costs."

Step 3: Specify Services Included

The SOW must explicitly list every task. Avoid generalities:

Vague SOW: "Consultant will prepare the 510(k) submission."
Specific SOW: "Consultant will perform the following services:
  • Conduct a comprehensive gap analysis of existing client documentation against FDA requirements
  • Perform predicate device research and selection, delivering a top-3 candidate report with justifications
  • Author the following 510(k) sections: 01-Executive Summary, 05-Device Description, 06-Performance Testing Bench, 12-Substantial Equivalence
  • Review and provide feedback on client-authored sections: 07-Biocompatibility, 08-Software
  • Compile the complete eCopy submission package formatted according to FDA's final guidance
  • Act as the primary contact for the FDA pre-submission meeting
  • Prepare responses to one round of FDA Additional Information (AI) requests
"

Step 4: Explicitly List Services Excluded

This is just as important as the included list. It clarifies boundaries:

Example Exclusions:
  • "This SOW excludes the performance or management of any laboratory testing (e.g., biocompatibility, sterilization, electrical safety)"
  • "Consultant is not responsible for creating or implementing the client's Quality Management System (QMS)"
  • "Services do not include travel to client facilities unless specified and billed separately"
  • "This SOW does not include FDA user fees or third-party software licenses"

Step 5: Define Deliverables

List the tangible things you will receive. This is proof of work:

Example Deliverables:
  • Gap Analysis Report (PDF, Word format)
  • Predicate Selection Justification Memo (Word Document)
  • First Draft of 510(k) Sections 01-10 (Word format, editable)
  • Final FDA-ready eCopy Submission Package (.zip file)
  • Meeting minutes from all FDA interactions
  • Weekly Project Status Reports (email format)

Critical: Ensure you receive editable source files (Word, Excel), not just final PDFs. You own this content and may need to reuse it.

Step 6: Discuss the "What Ifs"

What happens if the scope needs to change? Define a change order process:

Example Change Order Clause:

"Any services requested by Client that fall outside the scope of the SOW will be considered a scope change. Consultant will provide a written Change Order detailing the new work, timeline, and fees. No work on the scope change will begin until the Change Order is signed by both parties."

Scenarios to discuss:

  • What if the FDA asks for new testing?
  • Who pays for that? Who manages it?
  • What if you need a second round of biocompatibility?
  • What if the device design changes mid-project?

Step 7: Attach the Responsibility Matrix to the Contract

Make the detailed task list you created an official exhibit or addendum to the contract. The SOW should explicitly reference it. This makes it legally binding.

Warning: A contract with a one-sentence SOW is a recipe for disaster. If the consultant pushes back on adding a detailed task list, saying "it's too restrictive," that's a red flag.

Real-World Example: What Goes Wrong

A dental device company hired a consultant to "get them through the FDA." Three months in, the consultant sent them a list of 15 documents they needed the company to write, including:

The company's team was furious—they didn't have the time or expertise to create these from scratch and assumed the consultant's fee covered it. The relationship soured, the project stalled, and they had to renegotiate the contract for a much higher fee.

This could have been avoided with a clear responsibility matrix and explicit SOW.

Want Sample SOW Templates?

Our comprehensive 510k Consultant Engagement Guide includes:

  • Sample Statement of Work (SOW) outline
  • Responsibility matrix template
  • Contract clauses checklist
  • Change order process examples

Download the Free 40-Page Guide →

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