# fda-samd-mcp
# FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech and digital health firms.

## Install
```bash
pip install fda-samd-mcp
```

## Auth & Rate Limits
- Free tier: 10 calls/day. No API key required.
- Pro tier (£79/mo): unlimited + signed attestations.
- Enterprise (£1,499/mo): white-label + on-premise.

## Tools (5)

### `classify_sw_device(query, api_key)`
FDA SaMD vs SiMD classification + IMDRF risk framework

### `regulatory_pathway(query, api_key)`
510(k) / De Novo / PMA pathway selection

### `pccp_template(query, api_key)`
Predetermined Change Control Plan generator (locked vs adaptive AI)

### `good_ml_practice(query, api_key)`
FDA Good Machine Learning Practice (GMLP) 10 principles

### `ai_ml_action_plan(query, api_key)`
FDA AI/ML Action Plan focus area assessment

## Pairs with
- `meok-attestation-api` — HMAC signing for compliance certs
- `meok-attestation-verify` — public verification

## Maintainer
MEOK AI Labs · hello@meok.ai · https://meok.ai · MIT
