fda_submission_guide
Complete framework for 510(k), De Novo, and PMA submissions to the FDA.
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# FDA Submission Guide Complete framework for 510(k), De Novo, and PMA submissions to the FDA. --- ## Table of Contents - [Submission Pathway Selection](#submission-pathway-selection) - [510(k) Premarket Notification](#510k-premarket-notification) - [De Novo Classification](#de-novo-classification) - [PMA Premarket Approval](#pma-premarket-approval) - [Pre-Submission Program](#pre-submission-program) - [FDA Review Timeline](#fda-review-timeline) --- ## Submission Pathway Selection ### Dec
How to Use
Recommended: Install to project (local)
mkdir -p .claude/skills
curl -o .claude/skills/fda_submission_guide.md \
https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/fda-consultant-specialist/references/fda_submission_guide.mdSkill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.
Alternative: Clone full repo
git clone https://github.com/alirezarezvani/claude-skillsThen reference at ra-qm-team/fda-consultant-specialist/references/fda_submission_guide.md
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