510k Premarket Notification

Draft FDA 510(k) Submissions in Minutes, Not Weeks

15 minutes with CaseMark

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15 minutes with CaseMark

What you'll need

Device Technical File
Predicate Device Information
Performance and Testing Data

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

CaseMark's 510(k) Premarket Notification skill drafts complete FDA submission packages demonstrating substantial equivalence to predicate devices under 21 CFR Part 807. It supports Traditional, Special, and Abbreviated pathways, generating every required section from cover letters and device descriptions to detailed SE comparison tables and performance data summaries. The result is a submission-ready document package that meets CDRH formatting and content expectations.

Preparing a 510(k) premarket notification is one of the most time-intensive tasks in medical device regulatory affairs. Teams spend weeks manually drafting device descriptions, building substantial equivalence comparisons, and ensuring every section meets evolving FDA guidance—all while coordinating across engineering, quality, and clinical teams. A single omission or structural error can trigger costly additional information requests and delay device clearance by months.

CaseMark transforms the 510(k) drafting process by using AI to analyze your device technical files, predicate device information, and performance data, then generating a complete, structured submission package. Every section—from the cover letter and FDA Form 3514 guidance to the substantial equivalence comparison and labeling review—is drafted in alignment with CDRH expectations, giving regulatory teams a comprehensive first draft they can refine and finalize with confidence.

How it works

1. Upload your device technical file, predicate device details, and performance data
2. AI analyzes your documentation and structures a complete 510(k) submission package
3. Review the drafted sections including substantial equivalence analysis and device description
4. Export the finalized submission in your preferred format (DOCX, PDF)

What you get

Cover Letter to CDRH Division
FDA Form 3514 Completion Guide
Device Description
Substantial Equivalence Comparison
Performance Data Summary
Proposed Labeling Review
Submission Checklist and Compliance Notes

What it handles

Complete 510(k) submission package with cover letter, device description, and SE comparison
Support for Traditional, Special, and Abbreviated 510(k) pathways
Structured substantial equivalence analysis against predicate devices
FDA Form 3514 field mapping and completion guidance
Performance data and biocompatibility summary integration
Labeling and IFU review sections aligned with CDRH expectations

Required documents

Device Technical File
Engineering drawings, materials list, specifications, software architecture, and design documentation for the subject device
.pdf, .docx
Predicate Device Information
Predicate device trade name, manufacturer, K-number, clearance date, labeling, and available summary or decision documents
.pdf, .docx
Performance and Testing Data
Bench testing results, biocompatibility data (ISO 10993), clinical evidence, and literature references supporting substantial equivalence
.pdf, .docx, .xlsx

Supporting documents

Proposed Labeling Materials
Instructions for use, package inserts, patient materials, and packaging artwork for the subject device
.pdf, .docx
FDA Correspondence
Prior FDA communications, pre-submission meeting minutes, or additional information request letters for resubmissions
.pdf, .docx
Standards and Guidance References
Applicable recognized consensus standards, FDA guidance documents, or special controls referenced in the submission
.pdf, .docx

Why teams use it

Reduce 510(k) drafting time from weeks to hours with AI-structured submission packages

Ensure completeness with automated section generation aligned to FDA guidance and 21 CFR Part 807

Strengthen substantial equivalence arguments with structured predicate device comparison analysis

Minimize FDA additional information requests by addressing common reviewer expectations upfront

Questions

Which 510(k) submission pathways does this support?

CaseMark supports all three FDA 510(k) pathways: Traditional, Special, and Abbreviated. The AI adapts the submission structure and content requirements based on your selected pathway and device classification.

Can this tool handle software-enabled or AI/ML medical devices?

Yes. CaseMark's 510(k) drafting skill includes dedicated sections for software/firmware documentation, cybersecurity considerations, and AI/ML components. It structures these sections in alignment with current CDRH guidance documents.

How does the substantial equivalence analysis work?

CaseMark compares your device against the identified predicate device across intended use, technological characteristics, performance data, and safety profiles. It generates a structured SE comparison table and narrative that addresses each point of comparison FDA reviewers expect.

Does this replace the need for a regulatory affairs specialist?

CaseMark accelerates the drafting process and ensures structural completeness, but we recommend regulatory affairs professionals review all submissions before filing. The tool is designed to reduce drafting time from weeks to hours while maintaining FDA-compliant formatting.

What if my device has novel features not present in the predicate?

CaseMark flags novel features and ensures each one is explicitly addressed in the substantial equivalence comparison. The AI generates appropriate sections discussing how novel features do not raise new questions of safety or effectiveness.

Can I use this for resubmissions or amendments?

Yes. CaseMark supports both original submissions and resubmissions. For resubmissions, the tool incorporates prior K-numbers and structures responses to FDA feedback or additional information requests.