You know how navigating FDA regulations can turn into a research project every time you need to verify a requirement or understand a compliance pathway? This puts an FDA consultant in your terminal who can answer questions about regulatory requirements, device classifications, clinical trial rules, and submission processes. Use it when you're scoping a medical device project, prepping documentation, or trying to figure out if your software qualifies as a medical device in the first place. It won't replace your actual regulatory team for submissions, but it's solid for initial research and sanity checking your assumptions before you loop in the expensive consultants.
npx skills add https://github.com/alirezarezvani/claude-skills --skill fda-consultant-specialist