# Fda Regulations

> FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

- name: io.github.pipeworx-io/fda-regulations
- version: 0.1.2
- connection class: R0 (autonomous)
- trust: 97/100
- quality: –/100 (not scored)
- owner: not claimed
- descriptor: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Ffda-regulations
- tools: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Ffda-regulations/tools

**An agent can connect right now, no human step.** Remote endpoint, no authentication, reachable on the last probe.

## Connection (mcpServers)

```json
{
  "mcpServers": {
    "fda-regulations": {
      "type": "http",
      "url": "https://gateway.pipeworx.io/fda-regulations/mcp"
    }
  }
}
```


## Trust

- hygiene: 100
- liveness: 99
- freshness: 100
- provenance: 90
- drivers: +repository +namespace-matches-repo +website +reachable +uptime-98% +updated-26d-ago
- Derived from observable signals (official registry feed and our own credential-free probes); no code audit performed.

## Quality –/100 (not scored)

Not scored: fewer than three checks apply, usually because no remote answered a credential-free probe or the server is a local package.

### protocol: 75 (weight 25)

- warn `protocol.modern`: newest supported version is 2025-03-26; 2026-07-28 not supported, older versions are deprecated until 2027-07-28
- n/a `protocol.stateless`: only applies to 2026-07-28 servers
- pass `protocol.transport`: streamable HTTP
- n/a `protocol.list_ttl`: only applies to 2026-07-28 servers

### authorization: n/a (weight 15)

- n/a `auth.prm`, `auth.as_metadata`, `auth.cimd`: no remote uses OAuth
- n/a `auth.secret_in_url`: no templated URL

### tool hygiene: n/a (weight 30)

- n/a `tools.descriptions`, `tools.description_length`, `tools.schemas`, `tools.annotations`, `tools.directory_hints`, `tools.token_cost`, `tools.api_dump`: tool list unknown (behind auth, not probed, or empty)

### stability: n/a (weight 15)

- n/a `stability.changes`, `stability.rug_pull`: tool list unknown

### dependencies: n/a (weight 15)

- n/a `deps.known_vulns`, `deps.mcp_sdk_version`, `deps.resolvable`: no npm or PyPI package

- tools: unknown
- tools last changed: 2026-10-18T06:37:18.483Z
- badge: [![protogrid quality](https://protogrid.dev/badge/io.github.pipeworx-io/fda-regulations.svg)](https://protogrid.dev/servers/io.github.pipeworx-io/fda-regulations)
- Checks run on what our credential-free, read-only probes observe; tools are never called and no code audit is performed.

### Tool changes

- 2026-10-18 `remember` removed
  - Save data the agent will need to reuse later — across this conversation or across sessions. Use when you discover something worth carrying forward (a resolved ticker, a target address, a user preference, a research subject) so you don't have to look it up again. Stored as a key-value pair scoped by your identifier. Authenticated users get persistent memory; anonymous sessions retain memory for 24 hours. Pair with recall to retrieve later, forget to delete.
- 2026-10-18 `pipeworx_feedback` removed
  - Tell the Pipeworx team something is broken, missing, or needs to exist. Use when a tool returns wrong/stale data (bug), when a tool you wish existed isn't in the catalog (feature/data_gap), or when something worked surprisingly well (praise). ONLY for tools served by this Pipeworx connection — if the tool came from a different MCP server in your client (another vendor's Gmail, Splunk, Slack, etc. connector), we cannot fix it and reporting it here only delays you; file it with that server instead. Not sure? Pipeworx tool names are the ones this connection lists. Describe the issue in terms of Pipeworx tools/packs — don't paste the end-user's prompt. Filing without an account returns a `claim_token`; pass it back later as pipeworx_feedback({claim_token:"pwfb_…"}) to read whether it was fixed and what changed. The team reads digests daily and signal directly affects roadmap. Rate-limited to 5 per identifier per day. Free; doesn't count against your tool-call quota.
- 2026-10-18 `polymarket_arbitrage` removed
  - Find arbitrage opportunities on Polymarket via monotonicity violations + partition-sum checks. Call with NO args for a `trending_scan` of the top ~200 markets by weekly volume; pass `event` for the strongest per-event partition_check, or `topic` for a themed cross-event scan. `event` (recommended for a specific market): pass a Polymarket event slug like "fed-decision-may-2026" or "when-will-bitcoin-hit-150k"; walks child markets, checks date-axis / threshold-axis ordering AND computes the partition_check (sum of YES prices across mutually-exclusive legs — should ≈1; deviations >3pp emit a BUY/SELL EVERY LEG signal). `topic` (for cross-event scanning): pass a seed question like "Strait of Hormuz traffic returns to normal" or "Fed rate decision"; searches related events across the platform, flattens markets, runs the comparator on the union. Cross-event mode catches "...by May 31" vs "...by Jun 30" patterns that single-event misses. SEMANTIC ANCHOR: cross-event pairs require ≥0.30 Jaccard similarity on question tokens (prevents Powell-Fed-Pause being paired with Powell-DOJ-probe); skipped_low_similarity surfaces the rejected pair count. PARTITION FILTER: drops will-person-X / will-manager-Y / will-someone-else- placeholder slugs; partitions with >20% placeholder fraction return null arb signal. Response: opportunities[] (gap_pp, suggested_trade, reasoning, monotonicity violation context), and in event mode partition_check{sum_yes_prices, gap_from_1, placeholders_filtered, suggested_trade}. FEES: every opportunities[] row and partition_check.arbitrage carry edge_pp_gross (== gap_pp / overround_pp), fees_pp, edge_pp_net, net_positive, plus polymarket_fee_pp, fee_basis and fee_categories[]. BOTH cost components are modeled: Polymarket's own per-category TAKER FEE (fee = shares × rate × p × (1-p), rates crypto 0.07 / sports-economics-culture-weather-other 0.05 / finance-politics-mentions-tech 0.04, geopolitics and world events fee-free; verified against Polymarket's own docs as of 2026-09-13) and Polygon gas (~$0.02/leg). The taker fee dominates: ~$1.75 per 100 shares on a crypto market at 50c versus $0.02 of gas, so rows that looked profitable before fleet #1927 may now show net_positive:false — that is the correction, not a regression. Each leg is priced at ITS OWN market's rate and price (the fee curve peaks at 50c and falls toward both extremes). fee_basis says where the rate came from: 'payload' (read off the market, the normal case), 'category' (mapped from its fee category), 'fee_free', or 'fallback' (rate unknown — charged at the modal 0.05 rather than assumed free, so an unreadable market is never reported as costless). Where fill_check reprices against live depth, this does NOT double-count that spread cost. FILL CHECK: when the partition signal fires, arbitrage.fill_check prices it against live CLOB depth (theoretical_edge_pp_at_book vs realizable_edge_pp at 1000 shares/leg, thin_legs[]) — realizable_edge_pp ≤ 0 means the overround exists only at last-trade, not in the book; do not trade it. For custom sizing use polymarket_fill_risk.
- 2026-10-18 `unsubscribe` removed
  - Cancel a subscription by id. Ownership is enforced — you can only cancel your own subscriptions. The row is deactivated (not deleted) so its historical events stay available via recent_alerts.
- 2026-10-18 `polymarket_edges` removed
  - Scan top Polymarket markets and return opportunities where Pipeworx data disagrees with market price. Built for "what should I bet on today" — agents discover opportunities without paging hundreds of markets. FIVE MODEL FAMILIES grouped into three response segments under by_segment: (1) MODEL_DRIVEN — crypto_price (lognormal barrier from 90d FRED log-returns) and news_momentum (GDELT 7d/21d article-volume ratio, soft signal w/ halved Kelly). (2) STRUCTURAL_ARBITRAGE — partition_overround on mutually-exclusive events; per-leg favorite-longshot bias correction with per-sport α (tennis 1.02, soccer 1.10, MMA 1.15, default 1.0); placeholder-slug filter drops will-person-X / will-team-Y / will-manager-Z / will-someone-else- backstops; partitions with >20% placeholder fraction skipped entirely. (3) CONCENTRATED_LONGSHOT — basket trade when one leg ≥75% AND ≥2 longshots ≤8% AND portfolio return ≥25:1; rare-by-design (gates relaxed Run 8 from prior 85%/5%/50:1). EVERY OPPORTUNITY carries edge_pp_net (net of slippage AND Polymarket's own taker fee — fees_pp_applied itemises the fee component; see fees.ts for the published per-category schedule), kelly_fraction + kelly_fraction_half (capped at 0.25), market.liquidity, market.spread_pp, market.volume, plus a 24h-move warning ("Market moved X.Xpp in 24h") when the recent move alone exceeds the edge — your edge may already be in the price. TRADEABLE-EDGE KNOBS: min_liquidity / max_spread_pp drop opportunities where edge isn't realizable; min_partition_leg_kelly filters partitions by best per-leg Kelly. RESPONSE TOP-LEVEL: by_segment{model_driven,structural_arbitrage,concentrated_longshot}, fed_candidates/fed_note (Fed bets surface here, excluded from ranking — 1m-T vs EFFR signal is unreliable at meeting-month horizons without paid OIS/SOFR-futures data), and _diagnostics{concentrated_longshot:{...funnel counters},category_counts,filter_skips} so callers can see WHY a segment is empty (top-N stale, all candidates failed gates, knob dropped them). Cached 1h at the KV level keyed on all knobs.
- 2026-10-18 `ask_pipeworx_grounded` removed
  - Hallucination-resistant answer mode for high-stakes reads. Same routing as ask_pipeworx — picks the right tool from 6,919 across 1820 sources, fills arguments, fetches the data — then EXTRACTS the answer using ONLY what the tool result contains. Returns {answer, evidence (verbatim quote), confidence, source, fetched_at, refusal_reason:null} on success, OR an explicit refusal {answer:null, refusal_reason:"not_in_source"|"no_tool_match"|"tool_error"|"data_truncated"|"llm_error"} when the data doesn't directly answer. Use whenever an answer will be quoted, cited, or acted on, and the agent must not invent facts (financial verdicts, legal claims, medical lookups, public statements). Costs one extra LLM call vs ask_pipeworx — prefer ask_pipeworx for casual lookups.
- 2026-10-18 `scan_competitor_ai_presence` removed
  - Compare AI visibility across multiple entities side-by-side. Probes each entity (your brand + N competitors) with ai_visibility_check, ranks by score, surfaces which is most/least recognized. Useful for competitive AI-marketing audits: "does Claude know about us as well as our competitors?". Returns ranked list with score, confidence, signal density per entity.
- 2026-10-18 `fda_search` removed
  - Keyword search across FDA regulations — US Food & Drug Administration rules in 21 CFR. Answers "what FDA regulations cover X", "the FDA regulation / rule about X", "find the FDA requirement for X". Great for topics: good manufacturing practice (GMP / cGMP), quality system regulation, medical device labeling, drug labeling, nutrition facts / food labeling, new drug applications, dietary supplements, cosmetics, biologics, controlled substances, current good manufacturing practice for drugs and devices. Returns matching FDA regulations with citation (21 CFR), heading, excerpt, and source URL. This searches FDA REGULATIONS (regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Example: fda_search({ query: "medical device labeling" }); fda_search({ query: "good manufacturing practice", limit: 15 }). Keyless.
- 2026-10-18 `fda_regulation` removed
  - Get the full text of one FDA regulation — a US Food & Drug Administration rule codified in 21 CFR — by its citation. Returns the exact regulatory wording currently in force. Answers "what does 21 CFR 211 require", "what is the FDA regulation for X", "does the FDA require X", "read 21 CFR 211.100", "the FDA good manufacturing practice rule". Forgiving citation input: "211.100", "21 CFR 211.100", "§211.100", even "211.100(a)" (paragraph stripped to the section). Covers 21 CFR part 211 current good manufacturing practice (cGMP / GMP) for finished drugs, part 210 cGMP general, part 820 quality system regulation / QMSR for medical devices, part 801 medical device labeling, part 101 food labeling / nutrition facts, part 314 new drug applications (NDA/ANDA), part 807 device establishment registration, part 111 dietary supplement cGMP, part 1308 controlled substance schedules — the whole of Title 21 (food, drugs, devices, cosmetics, biologics). This is FDA REGULATIONS (the rules/regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Pass a whole part (e.g. "211" or "820") to get that part's section list. Example: fda_regulation({ citation: "211.100" }) -> written procedures / process control; fda_regulation({ citation: "21 CFR 101.9" }) -> nutrition labeling. Keyless.
- 2026-10-18 `recall` removed
  - Retrieve a value previously saved via remember, or list all saved keys (omit the key argument). Use to look up context the agent stored earlier — the user's target ticker, an address, prior research notes — without re-deriving it from scratch. Scoped to your identifier (anonymous IP, BYO key hash, or account ID). Pair with remember to save, forget to delete.

Full history: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Ffda-regulations/changes

## Remotes

- https://gateway.pipeworx.io/fda-regulations/mcp (streamable-http, auth none, reachable true, uptime30d 0.98275864)

## Packages

_none_

## Tools (0)

_none observed_