fda-med-device SKILL.md skillA
fda-med-device from jgsystemsconsulting/jgs-se-knowledge-packs is an agent skill: a SKILL.md folder an AI agent loads when a task calls for it.
mdr add jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device@git:20261013.30a6732Pins git:20261013.30a6732 in mdr.lock. Pin the fingerprint instead.
- Audit grade
- A, 17 of 17 checks passed
- Kind
- SKILL.md skill
- Repository
- jgsystemsconsulting/jgs-se-knowledge-packs
- Path
packs/fda-med-device/SKILL.md- Versions recorded
- 4
- Latest version
- git:20261013.30a6732, committed Oct 13, 2026
- First version recorded
- Oct 12, 2026
- Size
- 15,733 bytes
- Repository stars
- 71
- License
- a license file GitHub does not identify
Reconstructed reference notes on US FDA medical-device software regulation, built from seven public-domain FDA sources (the QMSR final rule 89 FR 7496, FDA device software guidance documents, and the eSTAR program page; pinned 2026-10-12). Use for regulatory pathways and premarket submissions (510(k), De Novo, PMA, eSTAR), premarket software documentation levels (Basic or Enhanced), software validation and Computer Software Assurance, the Quality Management System Regulation…
Collected from public GitHub. Every version is saved exactly as it was and never changes. Install it at an exact version with the mdr tool, and every file is checked before it reaches your agent. The main file is checked against the SHA-256 fingerprint recorded here, and the others against the fingerprints GitHub keeps for its source commit. The automatic checks below grade the latest version, and the same checks always give the same file the same grade.
What the file says
<!-- argument-hint: [FDA device software topic, regulation question, submission section, chapter number] --> # FDA Device Software Guidance and the QMSR **Source**: U.S. FDA (CDRH/CBER). Adapted from the sibling 2026-09-24 prototype build and re-checked against the 2026-10-12 FDA source pin, the seven documents vetted in LICENSE as rows S1-S4 and S6-S8 | **Licence**: Public Domain (US Government work, 17 U.S.C. 105) | **Chapters**: 12 ## When to use **Prerequisites:** none: plain Markdown; no MCP server, API key, or licence tier needed at runtime. Use this skill for US FDA questions about software in or around medical devices: what documentation a premarket submission needs, how software must be validated, what the Quality Management System Regulation requires after the 2026-02-02 transition, what cybersecurity artifacts FDA expects, where a software function stops being a device (clinical decision support, MDDS), when a software change triggers a new 510(k), and how eSTAR structures the submission. The pack answers with FDA's own frameworks, cited by chapter and source row. ## How to Use This Skill …
Read the whole file at its exact version.
How to install
mdr add jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device@sha256:8d7ba143bd30837cThe line at the top of this page pins the label git:20261013.30a6732, which is what most people want. This one pins the sha256 fingerprint of the contents instead, so it survives a label being moved. Either way the exact version is written to mdr.lock, and mdr install downloads and checks those contents again, so it installs them exactly or stops with an error.
[](https://markdownregistry.com/a/art_bvmty6mezqqaed3i)
1 badge image fetches in 30 days. What the badge shows.
Versions
The registry has recorded 4 versions of this file, between Oct 12, 2026 and Oct 13, 2026, more than one a day.
| version | committed | commit | size | audit | |
|---|---|---|---|---|---|
| git:20261013.30a6732 latest | 2026-10-13 | 30a6732 | 15,733 B | A | view · diff |
| git:20261012.00b6532 | 2026-10-12 | 00b6532 | 15,757 B | A | view · diff |
| git:20261012.9412b50 | 2026-10-12 | 9412b50 | 15,708 B | A | view · diff |
| git:20261012.cbf80dc | 2026-10-12 | cbf80dc | 15,219 B | A | view |
Audit of the latest version
- pass: Frontmatter block present
- pass: Frontmatter declares a name
- pass: Frontmatter declares a description
- pass: Size between 200 bytes and 200 KB (15733 bytes)
- pass: No zero-width or bidi control characters
- pass: No instruction hidden inside an HTML comment
- pass: No link to an exfiltration or paste host
- pass: No credential-shaped string
- pass: No instruction to send local credentials anywhere
- pass: No text hidden with inline styles
- pass: No prompt-injection phrasing
- pass: No curl or wget piped into a shell
- pass: No recursive delete of root, home or parent
- pass: No instruction to read or print local credentials
- pass: No base64 blob over 200 characters
- pass: No link to a raw IP address
- pass: No script tag
Source
jgsystemsconsulting/jgs-se-knowledge-packs · 71 stars · license a license file GitHub does not identify · pushed 2026-11-04 · branch main
API
GET https://markdownregistry.com/api/v1/artifacts/art_bvmty6mezqqaed3i GET https://markdownregistry.com/api/v1/resolve?ref=jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device GET https://markdownregistry.com/api/v1/blob/8d7ba143bd30837c27ffa022c6b5d2bc22f7b2ba54406a6d44c4427b233c2362
Your AI assistant does the legwork. You hear about the deals worth your word. Hand yours the standing instructions at modelranch.com and it joins the network that reads files like this one.
Guides: the SKILL.md format and its required fields · what to check before you install a skill · how to pin a skill to an exact version · where to find agent skills · keeping a team on the same skills · which agent file does what.