Preparing a 510(k) premarket notification manually requires extensive regulatory knowledge, meticulous document compilation, and countless hours formatting complex technical data into FDA-compliant submissions. Attorneys and regulatory specialists spend days cross-referencing predicate devices, organizing performance data, and ensuring every required section meets FDA standards—time that could be spent on strategic regulatory counsel.
Preparing a 510(k) premarket notification manually requires extensive regulatory knowledge, meticulous document compilation, and countless hours formatting complex technical data into FDA-compliant submissions. Attorneys and regulatory specialists spend days cross-referencing predicate devices, organizing performance data, and ensuring every required section meets FDA standards—time that could be spent on strategic regulatory counsel.
CaseMark automates the entire 510(k) drafting process by intelligently extracting data from your technical documents, generating compliant comparisons to predicate devices, and producing submission-ready documents in minutes. Our AI understands FDA regulatory requirements and structures your submission with all required sections, statements, and formatting—transforming a multi-day project into a streamlined 12-minute process.
This workflow is applicable across multiple practice areas and use cases
Healthcare law attorneys advising medical device manufacturers, hospitals, and healthcare systems need to prepare and review 510(k) submissions for medical device compliance and regulatory clearance.
Medical device regulation is a core component of healthcare law practice, and 510(k) submissions are essential regulatory filings that healthcare attorneys frequently handle for clients in the medical device industry.
M&A attorneys conducting due diligence on medical device companies need to review existing 510(k) submissions and assess regulatory compliance status as part of valuation and risk assessment.
FDA regulatory clearances and pending 510(k) submissions are critical assets and liabilities in medical device company acquisitions, directly impacting deal structure, valuation, and representations and warranties.
VC and PE attorneys representing investors in medical device startups need to evaluate 510(k) regulatory pathways and submission status as part of investment due diligence and portfolio company support.
Successful 510(k) clearance is often a critical milestone for medical device startup funding rounds and exit strategies, making regulatory submission capabilities essential for investment counsel.
IP litigators handling medical device patent disputes need to analyze 510(k) submissions to understand device specifications, intended use, and predicate device comparisons for infringement and validity arguments.
510(k) submissions contain detailed technical specifications and predicate device comparisons that are frequently used as evidence in patent litigation involving medical devices, particularly for claim construction and infringement analysis.
CaseMark is built on FDA regulatory frameworks and trained on successful 510(k) submissions. The platform automatically includes all required sections—cover letter, Form 3514, device description, intended use, predicate comparison, performance data, labeling, and required statements—ensuring your submission is structurally compliant and complete before filing.
Yes. CaseMark analyzes your device specifications and generates structured predicate device comparisons highlighting substantial equivalence. Simply upload your device documentation and predicate information, and the platform will create a comprehensive comparison table showing technological characteristics, intended use, and performance similarities required by FDA.
CaseMark processes bench testing results, animal study data, clinical trial outcomes, biocompatibility reports, and other performance documentation. The platform extracts key findings and organizes them into FDA-compliant summaries, ensuring your performance data is presented clearly and meets regulatory expectations.
Most users generate complete, submission-ready 510(k) documents in 10-15 minutes. This includes uploading your technical documents, reviewing AI-generated sections, and making any necessary customizations. What traditionally takes 12+ hours of manual work is reduced to minutes, allowing you to focus on regulatory strategy rather than document formatting.
CaseMark produces submission-ready drafts that include all required sections and proper formatting. However, we always recommend attorney or regulatory specialist review before FDA submission to ensure accuracy of technical details, strategic positioning, and alignment with your specific regulatory strategy. The platform handles the heavy lifting so you can focus on high-value review and refinement.
Yes. CaseMark can generate either a 510(k) Summary (detailed device information made publicly available) or a 510(k) Statement (declaration that safety and effectiveness information will be provided upon request). You specify your preference, and the platform formats the appropriate documentation according to FDA requirements.
CaseMark accommodates complex submissions requiring special controls, additional performance testing, or unique regulatory considerations. The platform's flexible input system allows you to upload supplementary documentation, and the AI will incorporate this information into the appropriate sections while maintaining FDA-compliant structure and formatting.