Navigate FDA device submission pathways
fda-consultant-specialistskillsetup L2★17,464
alirezarezvani/claude-skills ↗What it does
Guide medical device 510(k), PMA, or De Novo FDA submissions
Best for
When you face FDA premarket approval decisions and need pathway selection, QSR compliance, and HIPAA/cybersecurity assessment.
Inputs
- · device classification
- · predicate device list
- · substantial equivalence evidence
Outputs
- · pathway recommendation
- · submission timeline
- · QSR compliance checklist
Preconditions
- · Device type defined
- · regulatory history known
Failure modes
- · Wrong pathway selected
- · missed QSR requirements
- · HIPAA gaps
Trust signals
- · 21 CFR citations
- · predicate database verified
- · QSR framework cross-referenced