fda-classification-advisor SKILL.md skillA
fda-classification-advisor from alexclowe/awesome-copilot-cowork-plugins is an agent skill: a SKILL.md folder an AI agent loads when a task calls for it.
mdr add alexclowe/awesome-copilot-cowork-plugins/fda-classification-advisor@git:20260512.09751ecPins git:20260512.09751ec in mdr.lock. Pin the fingerprint instead.
- Audit grade
- A, 17 of 17 checks passed
- Kind
- SKILL.md skill
- Repository
- alexclowe/awesome-copilot-cowork-plugins
- Path
healthcare-compliance-officer/skills/fda-classification-advisor/SKILL.md- Versions recorded
- 1
- Latest version
- git:20260512.09751ec, committed May 12, 2026
- Size
- 3,556 bytes
- Repository stars
- 21
- License
- MIT
Determine the appropriate FDA premarket pathway for an AI-enabled medical device based on intended use and predicate landscape.
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
You have deep expertise in FDA medical-device classification and premarket pathway selection for AI/ML-enabled software as a medical device (SaMD). When the user is scoping a submission strategy, apply this knowledge automatically. ## Core competencies **Pathway decision logic:** - **510(k)** — Class II device with a legally marketed predicate; demonstrate Substantial Equivalence on intended use and technological characteristics - **De Novo** — novel low-to-moderate risk device with no suitable predicate; risk-based classification request under section 513(f)(2) - **PMA** — Class III device or high-risk novel device; requires valid scientific evidence of safety and effectiveness - **510(k) Special** — modifications to a manufacturer's own cleared device that affect specifications but not technological characteristics - **510(k) Abbreviated** — when an FDA guidance, special control, or recognized standard applies - **Exempt** — Class I devices and some Class II devices listed in 21 CFR 862–892 - **CDS carve-out** — section 520(o)(1)(E) excludes certain non-device clinical decision support; check the four prongs from the September 2022 final guidance **AI-specific overlays:** …
Read the whole file at its exact version.
How to install
mdr add alexclowe/awesome-copilot-cowork-plugins/fda-classification-advisor@sha256:b6079a65ca107f2fThe line at the top of this page pins the label git:20260512.09751ec, 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_ywnfwm6fbmbi63oz)
1 badge image fetches in 30 days. What the badge shows.
Versions
The registry has recorded 1 version of this file, committed on May 12, 2026.
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 (3556 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
alexclowe/awesome-copilot-cowork-plugins · 21 stars · license MIT · pushed 2026-10-12 · branch main
API
GET https://markdownregistry.com/api/v1/artifacts/art_ywnfwm6fbmbi63oz GET https://markdownregistry.com/api/v1/resolve?ref=alexclowe/awesome-copilot-cowork-plugins/fda-classification-advisor GET https://markdownregistry.com/api/v1/blob/b6079a65ca107f2fa8453670c72dbeb353120a07f3206d0741468e37fd2839c0
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.