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510k Premarket Notification

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

15 minutes with CaseMark

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510k Premarket Notification

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Workflow

510k Premarket Notification

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 and generates every required section—from cover letters and FDA Form 3514 content to device descriptions, SE comparisons, and performance data summaries. The result is a comprehensive first draft that dramatically reduces the time regulatory teams spend on initial submission preparation.

Drafting a 510(k) premarket notification is one of the most time-intensive tasks in medical device regulatory affairs. Teams spend weeks assembling device descriptions, constructing substantial equivalence arguments, cross-referencing predicate devices, and ensuring every FDA-required section is complete—all while navigating evolving guidance documents and risking costly Refuse to Accept letters for missing content.

CaseMark's AI-powered 510(k) drafting workflow transforms this process by analyzing your technical device file and predicate device information to generate a structured, comprehensive submission draft. The AI builds the substantial equivalence comparison, populates all required sections, and flags areas needing additional data—giving your regulatory team a polished starting point instead of a blank page.

How it works

  1. 1. Upload your technical device file, predicate device details, and performance testing data

  2. 2. AI analyzes device characteristics and builds a structured substantial equivalence argument

  3. 3. Review and customize the generated 510(k) submission sections and comparison tables

  4. 4. Export the complete submission package in your preferred format (DOCX, PDF)

What you get

  • Cover Letter to CDRH

  • FDA Form 3514 Content

  • Device Description

  • Substantial Equivalence Comparison

  • Performance Data Summary

  • Proposed Labeling Section

  • Biocompatibility Assessment

  • Software and Cybersecurity Documentation

What it handles

  • Generates complete 510(k) submission packages with all required FDA sections

  • Supports Traditional, Special, and Abbreviated 510(k) pathways

  • Builds structured substantial equivalence comparisons against predicate devices

  • Drafts device descriptions, performance data summaries, and proposed labeling sections

  • Auto-populates FDA Form 3514 fields and cover letter with CDRH division addressing

  • Flags biocompatibility, cybersecurity, and software considerations per current FDA guidance

Required documents

  • Technical Device File

    Device specifications, engineering drawings, materials list, software architecture, and manufacturing details

    .pdf, .docx

  • Predicate Device Information

    Predicate device trade name, manufacturer, K-number, clearance date, and available technical specifications

    .pdf, .docx

  • Performance Testing Data

    Bench testing results, biocompatibility data (ISO 10993), and clinical or literature evidence supporting equivalence

    .pdf, .docx, .xlsx

Supporting documents

  • Proposed Labeling

    Instructions for use, package inserts, patient materials, and packaging artwork

    .pdf, .docx

  • Biocompatibility Assessment

    ISO 10993 biological evaluation plan and test reports for patient-contacting materials

    .pdf, .docx

  • Software Documentation

    Software level of concern, architecture diagrams, cybersecurity risk assessment, and AI/ML algorithm descriptions

    .pdf, .docx

  • Prior FDA Correspondence

    Pre-submission meeting minutes, previous 510(k) decisions, or FDA feedback letters relevant to the device

    .pdf, .docx

Why teams use it

Reduce 510(k) drafting time from weeks to hours with AI-generated submission sections that follow FDA-expected structure and content requirements

Ensure completeness by systematically addressing every required section, reducing the risk of FDA Refuse to Accept decisions

Build stronger substantial equivalence arguments with structured, side-by-side predicate device comparisons across all critical dimensions

Maintain consistency across submissions with standardized formatting, terminology, and regulatory language aligned with CDRH expectations

Questions

Which 510(k) pathways does this tool support?

CaseMark supports all three FDA 510(k) pathways: Traditional, Special, and Abbreviated. The AI tailors the submission structure, required sections, and level of detail based on the pathway you select.

Does this replace the need for a regulatory affairs specialist?

CaseMark is designed to accelerate the drafting process, not replace regulatory expertise. The AI generates a comprehensive first draft that your regulatory affairs team can review, refine, and finalize before submission to the FDA.

How does the AI handle substantial equivalence analysis?

CaseMark systematically compares your device against the predicate device across intended use, technological characteristics, performance data, and safety profiles. It identifies similarities and differences, then constructs a structured equivalence argument aligned with FDA expectations.

Can it handle devices with software, AI/ML, or cybersecurity components?

Yes. CaseMark recognizes when software, firmware, AI/ML algorithms, or cybersecurity considerations apply and generates the appropriate documentation sections per current FDA guidance, including software level of concern and cybersecurity risk frameworks.

What types of documents do I need to upload?

At minimum, you should upload your technical device file (specifications, drawings, materials), predicate device information (K-number, clearance details), and performance testing data. Additional documents like proposed labeling and biocompatibility reports improve the output quality.

How current is CaseMark's knowledge of FDA 510(k) requirements?

CaseMark's 510(k) drafting workflow is built on 21 CFR Part 807, Subpart E requirements and aligns with current CDRH guidance documents. However, you should always verify the final submission against the latest FDA guidance before filing.

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