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510k Premarket Notification

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

15 minutes with Para

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Para is an AI colleague for legal teams. Send it this work by email, Teams or Slack, and it hands back the finished document.

15 minutes with Para

What you'll need

  • Device Technical File
  • Predicate Device Documentation
  • Performance and Testing Data

Plans from $20 a month, with usage included.

Workflow

Overview

CaseMark's 510(k) Premarket Notification skill automates the drafting of complete FDA submission packages for Class II medical devices. It structures every required section — from cover letters and FDA Form 3514 to substantial equivalence analyses and performance data summaries — ensuring compliance with 21 CFR Part 807 across Traditional, Special, and Abbreviated pathways.

Drafting a 510(k) Premarket Notification is one of the most document-intensive tasks in medical device regulatory affairs. Teams spend weeks assembling technical files, structuring substantial equivalence arguments, completing FDA forms, and cross-referencing performance data against predicate devices — all while ensuring strict compliance with 21 CFR Part 807 requirements.

CaseMark automates the heavy lifting of 510(k) submission drafting. Upload your device technical file, predicate documentation, and test data, and the AI generates a complete, structured submission package with substantial equivalence tables, device descriptions, and all required sections — ready for expert review and FDA submission.

How to hand this to Para

  1. 1. Send Para the files

    Email them, drop them in a Teams or Slack message, or upload them.

  2. 2. Para runs the 510k Premarket Notification skill

    It works from your files and checks its citations against the record.

  3. 3. The finished document comes back

    Para returns it where you asked, usually as a DOCX, and offers the next step.

Example request · email, Teams or Slack
Para, run the 510k Premarket Notification skill for the Garcia matter. I've attached the Device Technical File, Predicate Device Documentation and Performance and Testing Data. Send the finished draft back here as a DOCX.

What Para does

  1. 1. Upload your device technical file, predicate device documentation, and performance test data
  2. 2. AI analyzes your device against the predicate and structures the complete 510(k) submission
  3. 3. Review and customize each section including substantial equivalence tables and device descriptions
  4. 4. Export the finalized submission package in your preferred format (DOCX, PDF)

What you get

  • Cover Letter to CDRH Division

  • FDA Form 3514 Completion

  • Device Description and Specifications

  • Substantial Equivalence Comparison

  • Performance Data Summary

  • Proposed Labeling Section

What it handles

  • Complete 510(k) submission package with cover letter, FDA Form 3514, and all required sections

  • Substantial equivalence comparison tables mapping device features against predicate devices

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

  • Detailed device description with materials, software, sterility, and safety documentation

  • Performance data organization including bench testing, biocompatibility, and clinical evidence

  • Proposed labeling and IFU integration with regulatory cross-references

Required documents

  • Device Technical File

    Engineering drawings, materials lists, software architecture, specifications, and design documentation for the subject device

    .pdf, .docx

  • Predicate Device Documentation

    Predicate device trade name, manufacturer, 510(k) number, clearance details, and any available technical specifications

    .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 (IFU), package inserts, patient materials, and packaging artwork for the device

    .pdf, .docx

  • Prior FDA Correspondence

    Any pre-submission meeting minutes, FDA feedback letters, or prior 510(k) submissions related to this device

    .pdf, .docx

  • Standards and Guidance References

    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 comprehensive substantial equivalence analysis with automated predicate comparison tables

Minimize FDA rejection risk with properly structured sections that follow current CDRH guidance

Free your regulatory affairs team to focus on strategic review rather than document assembly

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, required sections, and level of detail based on the pathway you select, ensuring compliance with the specific requirements of each.

How does the AI handle substantial equivalence analysis?

CaseMark generates detailed comparison tables mapping your device's characteristics against the predicate device across all relevant dimensions — intended use, technological characteristics, performance data, and safety profiles. You review and refine the analysis before finalizing.

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

Yes. CaseMark includes dedicated sections for software architecture, cybersecurity documentation, and AI/ML components when applicable. The AI identifies when these sections are needed based on your device technical file and structures them per current FDA guidance.

Does this replace the need for a regulatory affairs specialist?

CaseMark dramatically accelerates the drafting process, but the output should be reviewed by a qualified regulatory affairs professional before submission to the FDA. The tool handles the heavy lifting of structuring, cross-referencing, and drafting so your team can focus on strategic review.

How current is the regulatory framework used?

CaseMark's 510(k) skill is built on 21 CFR Part 807, Subpart E requirements and aligns with current CDRH guidance documents. However, users should always verify against the latest FDA guidance, as regulatory requirements can evolve.

What if my device has no clear predicate?

If substantial equivalence is difficult to establish, CaseMark will still draft the submission based on your inputs, but the tool will flag areas where the equivalence argument may be weak. In cases where no predicate exists, a De Novo or PMA pathway may be more appropriate.

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