npm - fda-mcp-server - Versions diffs - 0.0.7 → 0.0.9 - Mend

fda-mcp-server 0.0.7 → 0.0.9

This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.

Files changed (6) hide show

package/README.md CHANGED Viewed

@@ -1,19 +1,18 @@
 # fda-mcp-server
-Query FDA Warning Letters, Form 483 Inspections, and Recalls directly from Claude. Built for quality engineers, regulatory professionals, and compliance teams working in FDA-regulated industries.
+FDA compliance intelligence tools for Claude, Cursor, and any MCP client. Query recalls, adverse events, warning letters, and CSA risk data directly from your AI assistant.
-No API key required for core tools. Just install and start asking questions.
+No API key required for free tools. Subscribe for enriched CSA analysis.
 ## What You Can Do
-**Ask Claude things like:**
+**Free — ask Claude things like:**
-- "Show me recent warning letters from CDRH mentioning software validation"
-- "Find Class I device recalls from the last 6 months"
-- "Pull up the enforcement profile for Siemens Healthcare"
-- "What 483 inspections happened in New Jersey for medical devices?"
+- "Find Class I device recalls from Medtronic"
+- "Show me adverse events for Philips ventilators"
+- "Pull up the enforcement profile for Exactech"
-**With the enriched dataset (API key required):**
+**Pro ($49/mo) — enriched dataset:**
 - "Run a CSA risk assessment on Fresenius Kabi"
 - "Generate a supplier qualification report for Baxter International"
@@ -21,42 +20,33 @@ No API key required for core tools. Just install and start asking questions.
 ## Tools
-### Free (live FDA data)
+### Free (live openFDA data)
 | Tool | What it does |
 |------|-------------|
-| `search_warning_letters` | Search warning letters by company, keyword, issuing office, or date range |
-| `search_483_inspections` | Search Form 483 observations by firm, state, FDA center, or project area |
-| `search_recalls` | Search recalls by product type, classification, firm, or date |
-| `company_enforcement_profile` | Warning letters + 483s + recalls for a single company in one view |
+| `search_recalls` | Search recalls by product type, classification, firm, state, or date range |
+| `search_device_events` | Search MAUDE adverse events by manufacturer, brand, event type, or date |
+| `company_enforcement_profile` | Recalls + adverse events (+ warning letters and 483s with Pro key) |
-### Enriched (curated CSA dataset, API key required)
+### Pro (enriched CSA dataset, API key required)
 | Tool | What it does |
 |------|-------------|
 | `csa_risk_assessment` | Risk score with 4.2x escalation multiplier, failure modes, citation breakdown |
-| `citation_analysis` | Citation patterns by CFR part, section, and category with CSA-relevant percentages |
-| `supplier_qualification_report` | Audit-ready qualification brief with risk level and go/no-go recommendation |
+| `citation_analysis` | Citation patterns by CFR part, section, and category with CSA percentages |
+| `supplier_qualification_report` | Audit-ready qualification brief with risk level and recommendation |
-The enriched tools are powered by a curated dataset of 1,047 warning letters, 1,800 Form 483s, 3,400 extracted citations, and 157 failure modes — all classified for CSA relevance. This is especially valuable for CDRH-regulated firms navigating the QMSR transition.
+The enriched tools are powered by 1,047 classified warning letters, 6,714 Form 483 observations, 3,600+ extracted citations, and 157 failure modes — all classified for CSA relevance across the QSR-to-QMSR regulatory transition.
 ## Setup
 ### Prerequisites
-Install [Node.js](https://nodejs.org/) (v18 or later). Download the LTS version from [nodejs.org](https://nodejs.org/) and run the installer.
-To check if it's already installed, open Terminal (Mac) or Command Prompt (Windows) and type:
-```
-node --version
-```
+[Node.js](https://nodejs.org/) v18 or later.
 ### Claude Desktop
-1. Open Claude Desktop
-2. Click the **gear icon** (Settings) → **Developer** → **Edit Config**
-3. Paste this into the file that opens:
+Add to your Claude Desktop config (`Settings → Developer → Edit Config`):
 ```json
 {
@@ -69,14 +59,11 @@ node --version
 }
 ```
-4. Save the file and **restart Claude Desktop**
-5. Start a new conversation — you should see a hammer icon indicating FDA tools are available
+Restart Claude Desktop. You should see a hammer icon indicating FDA tools are available.
-That's it. You can now ask Claude about FDA warning letters, 483s, and recalls.
+### Enabling Pro Tools
-### Enabling Enriched Tools
-To unlock CSA risk assessments, citation analysis, and supplier qualification reports, add your API key:
+Get an API key at [fda-mcp.jasencarroll.com](https://fda-mcp.jasencarroll.com), then add it to your config:
 ```json
 {
@@ -85,40 +72,34 @@ To unlock CSA risk assessments, citation analysis, and supplier qualification re
       "command": "npx",
       "args": ["-y", "fda-mcp-server"],
       "env": {
-        "FDA_API_KEY": "your-api-key-here"
+        "FDA_API_KEY": "fda_live_your-key-here"
       }
     }
   }
 }
 ```
-Get an API key at [jasenc.dev/fda-mcp](https://jasenc.dev/fda-mcp).
 ### Claude Code
 ```bash
 claude mcp add fda -- npx -y fda-mcp-server
 ```
-With enriched tools:
+With Pro tools:
 ```bash
-claude mcp add fda -e FDA_API_KEY=your-api-key-here -- npx -y fda-mcp-server
+claude mcp add fda -e FDA_API_KEY=fda_live_your-key-here -- npx -y fda-mcp-server
 ```
 ## Data Sources
-All core tool data comes from public FDA sources — no authentication required:
-- **Warning Letters** — FDA.gov (~3,300+ records, updated continuously)
-- **Form 483 Inspections** — FDA.gov FOIA Reading Room
-- **Recalls** — openFDA API (drugs, devices, food)
+Free tools use live public data from the [openFDA API](https://open.fda.gov/) (recalls, adverse events). No authentication required.
-Enriched tool data comes from a curated PostgreSQL database maintained at [fda-csa-data](https://github.com/jasencarroll/fda-csa-data). The dataset classifies each warning letter and 483 observation for CSA relevance based on CFR citations (21 CFR 211.68, 820.70(i), 820.30(g), Part 11) and narrative keywords (software validation, data integrity, electronic records, audit trail, etc.).
+Pro tools query a curated PostgreSQL database classifying FDA warning letters and 483 observations for CSA relevance based on CFR citations (21 CFR 211.68, 820.70(i), Part 11) and narrative analysis. Dataset maintained at [fda-csa-data](https://github.com/jasencarroll/fda-csa-data).
 ## Self-Hosting
-If you want to run the enriched tools against your own database instead of using an API key:
+Run enriched tools against your own database instead of using an API key:
 ```json
 {
@@ -142,4 +123,4 @@ MIT
 ## Author
-[Jasen Carroll](https://jasenc.dev) — Quality engineering + software, FDA-regulated industries.
+[Jasen Carroll](https://jasencarroll.com) — Quality engineering + software, FDA-regulated industries.

package/dist/db.d.ts CHANGED Viewed

@@ -18,12 +18,16 @@ export declare function getPool(): pg.Pool | null;
 export declare function isEnrichedAvailable(): boolean;
 /**
  * Validate API key for enriched tool access.
- * If FDA_MCP_API_KEY is set on the server, FDA_API_KEY must match.
- * If FDA_MCP_API_KEY is not set, access is open (local dev mode).
+ *
+ * Supports two modes:
+ * 1. HMAC-signed keys (fda_live_<payload>.<sig>) — validated with FDA_KEY_SECRET
+ * 2. Legacy simple match — FDA_API_KEY === FDA_MCP_API_KEY
+ * 3. No secret set — open access (local dev mode)
  */
 export declare function validateApiKey(): {
     valid: boolean;
     message?: string;
+    tier?: string;
 };
 export declare function testConnection(): Promise<boolean>;
 export interface CSARiskResult {

package/dist/db.d.ts.map CHANGED Viewed

	@@ -1 +1 @@
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package/dist/db.js CHANGED Viewed

@@ -13,6 +13,7 @@
  *
  * Schema: github.com/jasencarroll/fda-csa-data
  */
+import crypto from "node:crypto";
 import pg from "pg";
 const { Pool } = pg;
 let pool = null;
@@ -38,27 +39,74 @@ export function isEnrichedAvailable() {
 }
 /**
  * Validate API key for enriched tool access.
- * If FDA_MCP_API_KEY is set on the server, FDA_API_KEY must match.
- * If FDA_MCP_API_KEY is not set, access is open (local dev mode).
+ *
+ * Supports two modes:
+ * 1. HMAC-signed keys (fda_live_<payload>.<sig>) — validated with FDA_KEY_SECRET
+ * 2. Legacy simple match — FDA_API_KEY === FDA_MCP_API_KEY
+ * 3. No secret set — open access (local dev mode)
  */
 export function validateApiKey() {
-    const serverKey = process.env.FDA_MCP_API_KEY;
-    if (!serverKey)
-        return { valid: true }; // no key required (local mode)
+    const hmacSecret = process.env.FDA_KEY_SECRET;
+    const legacyKey = process.env.FDA_MCP_API_KEY;
+    // No secrets configured — open access (local/dev)
+    if (!hmacSecret && !legacyKey)
+        return { valid: true };
     const clientKey = process.env.FDA_API_KEY;
     if (!clientKey) {
         return {
             valid: false,
-            message: "Enriched tools require an API key. Set FDA_API_KEY in your MCP client config.\n\nGet a key at: https://jasenc.dev/fda-mcp",
+            message: "Enriched tools require an API key. Set FDA_API_KEY in your MCP client config.\n\nGet a key at: https://fda-mcp.jasencarroll.com",
         };
     }
-    if (clientKey !== serverKey) {
-        return {
-            valid: false,
-            message: "Invalid API key. Check your FDA_API_KEY value.",
-        };
+    // HMAC-signed key validation
+    if (hmacSecret && clientKey.startsWith("fda_live_")) {
+        const body = clientKey.slice("fda_live_".length);
+        const dotIndex = body.indexOf(".");
+        if (dotIndex === -1) {
+            return { valid: false, message: "Invalid API key format." };
+        }
+        const payloadB64 = body.slice(0, dotIndex);
+        const sigB64 = body.slice(dotIndex + 1);
+        try {
+            const payloadBytes = Buffer.from(payloadB64, "base64url");
+            const expectedSig = crypto
+                .createHmac("sha256", hmacSecret)
+                .update(payloadBytes)
+                .digest();
+            const actualSig = Buffer.from(sigB64, "base64url");
+            if (expectedSig.length !== actualSig.length ||
+                !crypto.timingSafeEqual(expectedSig, actualSig)) {
+                return { valid: false, message: "Invalid API key." };
+            }
+            const payload = JSON.parse(payloadBytes.toString("utf-8"));
+            if (payload.exp && payload.exp < Math.floor(Date.now() / 1000)) {
+                return {
+                    valid: false,
+                    message: "API key expired. Renew at https://fda-mcp.jasencarroll.com",
+                };
+            }
+            // Optional blocklist check
+            const blocklist = process.env.FDA_KEY_BLOCKLIST;
+            if (blocklist) {
+                const hash = crypto
+                    .createHash("sha256")
+                    .update(clientKey)
+                    .digest("hex");
+                if (blocklist.split(",").includes(hash)) {
+                    return { valid: false, message: "API key has been revoked." };
+                }
+            }
+            return { valid: true, tier: payload.tier };
+        }
+        catch {
+            return { valid: false, message: "Invalid API key." };
+        }
+    }
+    // Legacy simple key match
+    if (legacyKey && clientKey === legacyKey) {
+        return { valid: true };
     }
-    return { valid: true };
+    return { valid: false, message: "Invalid API key." };
 }
 export async function testConnection() {
     const p = getPool();

package/dist/db.js.map CHANGED Viewed

	@@ -1 +1 @@
1	- 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package/package.json CHANGED Viewed

@@ -1,6 +1,6 @@
 {
   "name": "fda-mcp-server",
-  "version": "0.0.7",
+  "version": "0.0.9",
   "description": "MCP server for FDA Warning Letters, Form 483 Inspections, and Enforcement/Recall data. Query FDA public data from any MCP client.",
   "type": "module",
   "main": "dist/index.js",