510(k)/PMA Templates
Working documents for a first FDA submission, not slideware. Checklists, cover letters, comparison tables and the Section 524B cybersecurity set, in editable Word and Excel. Register once with a work email and every file unlocks.
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510(k) Submission
The working documents for a Traditional 510(k) built in eSTAR: what to write, in what order, before a reviewer asks.
510(k) Submission Checklist (eSTAR)
Section-by-section eSTAR checklist with the attachment each section expects, who owns it, and the status column that keeps the team honest.
🔒 Unlock to download ↓ Download Excel510(k) Cover Letter
The cover letter FDA expects at the front of a 510(k): device, predicate, submission type, contact, and the sentences that matter.
🔒 Unlock to download ↓ Download WordIndications for Use Statement (Form 3881 Worksheet)
A worksheet for writing an Indications for Use statement that matches the predicate, the labeling and the testing.
🔒 Unlock to download ↓ Download WordSubstantial Equivalence Comparison Table
Side-by-side comparison of subject and predicate devices: indications, technology, performance, with a column for how each difference was resolved.
🔒 Unlock to download ↓ Download ExcelPredicate Device Search Log
Log every candidate predicate with its K number, product code, decision date and why it was kept or rejected.
🔒 Unlock to download ↓ Download Excel510(k) Summary
The public 510(k) Summary in the format 21 CFR 807.92 requires, pre-structured so the review team fills in facts, not headings.
🔒 Unlock to download ↓ Download WordPre-Submission (Q-Sub)
The cheapest meeting a startup will ever have with FDA. Ask the right questions and it pays for itself.
Pre-Submission Request Package
A Pre-Sub package outline: device description, regulatory strategy, proposed testing, and specific questions written so FDA can answer them.
🔒 Unlock to download ↓ Download WordRegulatory Strategy Memo
One memo that records the classification, pathway, predicate strategy, and risks, so everyone from the founder to the first regulatory hire works from the same page.
🔒 Unlock to download ↓ Download WordDe Novo and PMA
For devices without a predicate, or Class III devices where clinical evidence carries the submission.
De Novo Request Outline
The De Novo request structure: classification rationale, risks and mitigations table, special controls proposal, and the benefit-risk narrative.
🔒 Unlock to download ↓ Download WordPMA Module Planning Checklist
Modular PMA planning: which module holds what, dependencies, and a timeline that fits your clinical program.
🔒 Unlock to download ↓ Download ExcelBreakthrough Device Designation Request
A Breakthrough Devices designation request laid out against the four eligibility criteria FDA actually scores.
🔒 Unlock to download ↓ Download WordSoftware and Labeling
The sections reviewers send back most often on connected and software-driven devices.
Software Documentation Level Worksheet
Decide Basic or Enhanced documentation level under the 2023 software guidance and list every deliverable the level triggers.
🔒 Unlock to download ↓ Download WordLabeling and IFU Checklist
Labeling, instructions for use and UDI checklist mapped to 21 CFR 801 and the elements reviewers look for first.
🔒 Unlock to download ↓ Download ExcelCybersecurity (Section 524B) Sponsored by ELTON Cyber
The cybersecurity documents a cyber device needs in the submission: threat model, risk management, SBOM, and the postmarket plan.
Medical Device Cybersecurity
The governing procedure: roles, lifecycle gates, and how security work maps to design controls and the risk management file.
🔒 Unlock to download ↓ Download WordCybersecurity Risk Assessment
How to run a security risk assessment on a device: scope the system, rate exploitability against patient harm, and decide what blocks release.
🔒 Unlock to download ↓ Download WordCybersecurity Risk Assessments
The worksheet that goes with the assessment procedure. Threats, scoring, and residual risk in one place a reviewer can follow.
🔒 Unlock to download ↓ Download ExcelCybersecurity Risk Management Plan
A fill-in plan for how you will identify, evaluate, and control security risk across the product lifecycle.
🔒 Unlock to download ↓ Download WordCybersecurity Risk Management Report
The end-of-project record of what you found, what you fixed, and the risk you accepted, ready for a submission or an auditor.
🔒 Unlock to download ↓ Download WordThreat Modeling and Architectural Views
A repeatable method for threat modeling, including the architectural views FDA expects and how to turn findings into requirements.
🔒 Unlock to download ↓ Download WordThreat Model and Architectural Views
Captures data flows, trust boundaries, and threats so the model reads the same way from one product to the next.
🔒 Unlock to download ↓ Download WordSoftware Bill of Materials
Step by step: what to include, how to handle third-party and open-source components, and where teams usually slip.
🔒 Unlock to download ↓ Download WordSoftware Bill of Materials Report
A report shell for presenting your SBOM and its analysis alongside a submission.
🔒 Unlock to download ↓ Download WordSoftware Bill of Materials End of Support and Level of Support
Track end-of-support and level-of-support dates per component, so you can answer the questions reviewers now ask.
🔒 Unlock to download ↓ Download ExcelVulnerability Metrics Tracking
How to run postmarket vulnerability monitoring: intake, triage, and the metrics that show the program works.
🔒 Unlock to download ↓ Download WordVulnerability Metrics Tracking
A tracker for vulnerabilities and their metrics, so postmarket reporting is a lookup instead of a scramble.
🔒 Unlock to download ↓ Download ExcelThese templates are a starting point, not legal or regulatory advice. Adapt them to your quality system and your device. Provided free by MedDevice Startups.
Questions & Answers
Are the 510(k) and PMA templates really free?
Yes. Register once with a work email and all 25 documents unlock, in editable Word and Excel formats. The same registration adds you to the morning brief, and you can unsubscribe anytime.
What does the template library cover?
The 510(k) package (eSTAR checklist, cover letter, Indications for Use worksheet, substantial equivalence table, predicate search log, 510(k) Summary), the Pre-Submission package and regulatory strategy memo, De Novo and PMA planning, Breakthrough designation, software documentation level, labeling, and the Section 524B cybersecurity set: threat model, risk management, SBOM and postmarket vulnerability tracking.
Who sponsors the cybersecurity templates?
The cybersecurity group is sponsored by ELTON Cyber. The sponsorship is disclosed on the page and the sponsor does not write or review the editorial content on this site.
Can we adapt the documents to our quality system?
That is the intent. They are working starting points written for device startups, meant to be edited into your QMS and your device context. They are a baseline, not legal or regulatory advice.
ELTON Cyber is a medical device cybersecurity company. They pay for the cybersecurity desk and the Section 524B templates. They do not write the editorial and they do not review it before publication.
The reason is plain enough. Most device startups find their cybersecurity gap far too late to close it cheaply, and a company that understands the requirement early is a better customer later. A company that never needs the help is still better off knowing. Everything editorial here stays free and stays independent.
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