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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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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. Supporting Traditional, Special, and Abbreviated pathways, the AI generates all required sections—from cover letters and FDA Form 3514 to detailed device descriptions and substantial equivalence comparison tables. This enables regulatory affairs teams to produce comprehensive first drafts in a fraction of the time typically required.

Drafting a 510(k) premarket notification is one of the most time-intensive tasks in medical device regulatory affairs. Teams spend weeks manually assembling device descriptions, substantial equivalence analyses, performance data summaries, and labeling sections—often across dozens of documents. Errors, omissions, or inconsistencies can lead to FDA Refuse to Accept decisions, costly delays, and extended time-to-market.

CaseMark automates the heavy lifting of 510(k) drafting by analyzing your device technical files, predicate information, and performance data to generate a structured, comprehensive submission package. The AI ensures all required sections are present and properly organized, produces detailed substantial equivalence comparison tables, and flags areas needing additional evidence—giving your regulatory team a polished first draft to review and finalize rather than build from scratch.

How it works

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

  2. 2. AI analyzes your device against the predicate and structures all required 510(k) sections

  3. 3. Review and customize the generated submission package, including SE comparison tables

  4. 4. Export the complete 510(k) submission in your preferred format (DOCX, PDF)

What you get

  • Cover Letter

  • FDA Form 3514

  • Device Description

  • Substantial Equivalence Comparison

  • Performance Data Summary

  • Proposed Labeling Section

  • Submission Summary or Statement

What it handles

  • Complete 510(k) submission package with all required sections

  • Substantial equivalence comparison tables against predicate devices

  • Support for Traditional, Special, and Abbreviated 510(k) pathways

  • Automated device description with materials and software documentation

  • Performance data organization with ISO 10993 biocompatibility mapping

  • FDA Form 3514 field population and cover letter generation

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 details including trade name, manufacturer, 510(k) number, clearance date, indications for use, and available technical specifications

    .pdf, .docx

  • Performance Testing Data

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

    .pdf, .docx, .xlsx

Supporting documents

  • Proposed Labeling

    Draft instructions for use (IFU), package inserts, patient materials, and packaging artwork

    .pdf, .docx

  • FDA Correspondence

    Any prior FDA correspondence, pre-submission meeting minutes, or previous 510(k) decision letters relevant to the submission

    .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-generated submission packages that cover all required FDA sections

Ensure structural completeness with automated section generation aligned to 21 CFR Part 807 and current CDRH guidance

Generate thorough substantial equivalence comparisons with organized side-by-side analysis against predicate devices

Streamline documentation of complex device characteristics including software, cybersecurity, biocompatibility, and sterility

Questions

Which 510(k) submission pathways does this support?

CaseMark supports all three FDA 510(k) pathways: Traditional, Special, and Abbreviated. The AI tailors the submission structure and content requirements based on your selected pathway, ensuring compliance with the specific documentation standards for each.

How does the AI handle substantial equivalence analysis?

CaseMark generates detailed side-by-side comparison tables between your device and the predicate, covering intended use, technological characteristics, performance data, and safety profiles. The AI identifies similarities and differences, flagging areas that require additional supporting evidence.

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

Yes. CaseMark includes dedicated sections for software architecture documentation, cybersecurity considerations, and AI/ML components when applicable. The AI structures these sections according to current FDA guidance documents for software in medical devices.

Does this replace the need for a regulatory affairs specialist?

CaseMark is designed to accelerate the work of regulatory affairs professionals, not replace them. The AI generates a comprehensive first draft that your regulatory team can review, refine, and finalize—dramatically reducing the time from weeks of manual drafting to hours of focused review.

How does CaseMark ensure the submission meets current FDA requirements?

CaseMark structures submissions according to 21 CFR Part 807, Subpart E requirements and current CDRH guidance. The AI ensures all mandatory sections are included and properly organized. However, regulatory professionals should always verify compliance with the latest FDA guidance before submission.

What about biocompatibility and ISO 10993 documentation?

CaseMark identifies patient-contacting materials from your technical file and maps them to relevant ISO 10993 biocompatibility testing requirements. The AI organizes your biocompatibility data within the performance data section and flags any gaps in testing coverage.

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