Name: fda-consultant-specialist
Rating: 75.2 (1 reviews)
Author: alirezarezvani

fda-consultant-specialist

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Quality

94%

Does it follow best practices?

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Securityby

Passed

No findings from the security scan

The canonical home for this skill is fda-consultant-specialist in alirezarezvani/claude-skills

Quality

Content

88%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The body is well-organized and actionable with clear, validated workflows and a strong progressive-disclosure structure on paper. The main weakness is that the referenced bundle files (references/*.md and scripts/*.py) are advertised but absent from the actual skill bundle, slightly undermining navigation.

Suggestions

Provide the advertised references/*.md and scripts/*.py files (or remove the dangling references) so that the progressive-disclosure pointers resolve to real content.

De-clutter the Pathway Comparison table by stating the MDUFA fee basis once and dropping repeated '(FY2024)' annotations per row.

Consider tightening the dense QMSR-transition parenthetical into a short callout plus a reference, to reduce inline token weight.

Dimension	Reasoning	Score
Conciseness	Content is largely efficient — compact tables, terse decision trees, and step lists with no padding of basic concepts — but repeated '(FY2024)' fee labels and dense inline regulatory parentheticals add minor clutter that could be trimmed.	4 / 5
Actionability	It provides concrete, executable guidance: specific CLI commands ('python scripts/fda_submission_tracker.py /path/to/project --type 510k'), detailed tables for pathways, required sections, and RTA issues, and enumerated step sequences.	5 / 5
Workflow Clarity	Multi-step processes like the 510(k) workflow are clearly sequenced with explicit 'Checkpoint:' and 'Verification:' gates at each phase, and the Design Controls and CAPA workflows include per-step verification questions.	5 / 5
Progressive Disclosure	The body is a well-structured overview with clearly signaled one-level-deep inline 'Reference: See [x](references/x.md)' pointers and a Resources section, but the referenced references/ and scripts/ files do not actually exist in the bundle, so the disclosed navigation does not fully resolve.	4 / 5
	Total	18 / 20 Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

The description is strong across all dimensions: it states concrete capabilities, supplies a comprehensive natural trigger list, explicitly answers both what and when, and occupies a distinct regulatory niche in third person. It is a model of the score-5 anchor pattern.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete capability areas — '510(k)/PMA/De Novo pathway guidance', 'QMSR ... compliance', 'HIPAA assessments', and 'device cybersecurity' — giving comprehensive coverage of the domain rather than vague abstraction.	5 / 5
Completeness	It explicitly answers both 'what' (the four service areas) and 'when' via the concrete 'Use when user mentions ...' trigger clause, matching the score-5 anchor closely.	5 / 5
Trigger Term Quality	The 'Use when user mentions ... 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity' clause provides comprehensive natural trigger terms including regulatory synonyms and shorthand a user would actually say.	5 / 5
Distinctiveness Conflict Risk	The FDA/medical-device niche is clear with distinct regulatory triggers and third-person voice ('Provides ...'), giving minimal overlap risk with unrelated skills.	5 / 5
	Total	20 / 20 Passed

Validation

87%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 14 / 16 Passed

Validation for skill structure

Criteria	Description	Result
relative_links	Relative link issues: 4 missing	Warning
referenced_paths_exist	Referenced path issues: 7 missing	Warning

	Total	14 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: .gemini/skills/fda-consultant-specialist/SKILL.md
Commit: 19392f7

Reviewed: ~3 hours ago

Table of Contents

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