fda-med-device
From the author
Reconstructed reference notes on US FDA medical-device software regulation, built from seven public-domain FDA sources (the QMSR final rule 89 FR 7496, FDA device software guidance documents, and the eSTAR program page; pinned 2026-10-12). Use for regulatory pathways and premarket submissions (510(k), De Novo, PMA, eSTAR), premarket software documentation levels (Basic or Enhanced), software validation and Computer Software Assurance, the Quality Management System Regulation (QMSR, 21 CFR 820), medical-device cybersecurity (secure product development, SBOMs, FD&C Act section 524B, labelling), clinical decision support boundaries, off-the-shelf software, MDDS and other software-function scope questions, and the 510(k) software-change trigger. SCOPE LIMITS: US FDA device regulation only; no EU MDR or UKCA content (see `med-device-eu`); no ISO 13485, ISO 14971, or IEC 62304 text, which are named and summarized only as FDA obligations; no drug, biologic, or combination-product rules; reflects the pinned source da
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npx skills add jgsystemsconsulting/jgs-se-knowledge-packs --skill fda-med-device -a claude-code
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