# 🫀 FDA PMA Approval & Supplement Change Intelligence (`snuggly_beanie_970/fda-pma-supplement-change-intelligence`) Actor

Track FDA Class III device PMA approvals and supplements with materiality scoring, change themes, review duration, applicant activity and official evidence links.

- **URL**: https://apify.com/snuggly\_beanie\_970/fda-pma-supplement-change-intelligence.md
- **Developed by:** [Ilia](https://apify.com/snuggly_beanie_970) (community)
- **Categories:** Automation, Lead generation
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $4.00 / 1,000 enriched fda pma decisions

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.
Actors are written with capital "A".

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## 🫀 FDA PMA Approval & Supplement Change Intelligence

Monitor high-risk Class III medical-device approvals and understand what each PMA supplement actually changes. Results combine official decision data with deterministic materiality, review timing and competitive activity signals.

### 📤 What you get

- original PMAs and supplements with stable decision keys;
- supplement type, reason and full FDA approval-order statement;
- high/medium/low materiality based on new indications, clinical evidence, safety, design, labeling and manufacturing changes;
- review duration, expedited status and decision code;
- applicant and product-code activity counts inside the selected window;
- device identity, specialty, FEI/registration IDs, applicant address and direct FDA evidence links.

Use `minimumMateriality: "high"` to isolate panel-track supplements, indication expansions and other commercially meaningful changes. Schedule a weekly run for medtech competitive intelligence, regulatory monitoring or business-development leads.

Data comes from the official openFDA PMA endpoint, updated monthly.

### 📥 Complete input reference

| Field | Type | Default | Purpose |
|---|---|---:|---|
| `keywords` | array | `[]` | Match any phrase across trade/generic name, applicant, supplement reason and approval statement. |
| `applicants` | array | `[]` | Restrict results to one or more device applicants. |
| `productCodes` | array | `[]` | Restrict results to FDA product codes. |
| `decisionDateFrom` | string | `"2026-08-01"` | Inclusive YYYY-MM-DD lower bound. |
| `decisionDateTo` | string | `"2026-08-31"` | Inclusive YYYY-MM-DD upper bound. |
| `recordKinds` | array | `["original","supplement"]` | Choose original approvals and/or supplements. |
| `onlyApproved` | boolean | `true` | Keep APPR and accepted 30-day notice decisions. |
| `minimumMateriality` | string | `"all"` | Filter supplements by deterministic business/regulatory materiality. |
| `maxItems` | integer | `100` | Maximum PMA decisions to store. |

### 📤 Complete output reference

The default dataset is exportable as JSON, CSV, Excel, XML or RSS. Fields remain stable for scheduled runs and API integrations.

| Field | Type |
|---|---|
| `decisionKey` | string |
| `recordKind` | string |
| `pmaNumber` | string |
| `supplementNumber` | string |
| `tradeName` | string |
| `genericName` | string |
| `applicant` | string |
| `productCode` | string |
| `medicalSpecialty` | string |
| `deviceClass` | string |
| `decisionDate` | string |
| `dateReceived` | string |
| `reviewDays` | integer / null |
| `decisionCode` | string |
| `supplementType` | string |
| `supplementReason` | string |
| `approvalOrderStatement` | string |
| `materiality` | string |
| `materialityScore` | integer |
| `changeThemes` | array |
| `expeditedReview` | boolean |
| `applicantDecisionsInWindow` | integer |
| `productCodeDecisionsInWindow` | integer |
| `address` | string |
| `registrationNumbers` | array |
| `feiNumbers` | array |
| `officialPmaUrl` | string |
| `officialApiUrl` | string |
| `sourceLastUpdated` | string / null |
| `scrapedAt` | string |

### 🔌 API & integrations

Run this Actor from the Apify Console, API, CLI, MCP, Make, Zapier or n8n. Replace the Actor identifier and token in this template:

```bash
curl -X POST "https://api.apify.com/v2/acts/fda-pma-supplement-change-intelligence/runs?token=YOUR_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{}'
```

Results are stored in the run's default dataset and can be forwarded with Apify webhooks or scheduled Tasks.

### 🔎 Search keywords

FDA PMA Approval & Supplement Change Intelligence, fda, pma, approval, supplement, change, intelligence, Apify Actor, scraper API, structured data, scheduled monitor, automation.

### 💰 Pricing

Billing is tied to successfully delivered result events. Empty, filtered, duplicate or failed records are not charged as results. Open the **Pricing** tab for the current per-event rate before starting a run, and use Apify's maximum-charge control to enforce a hard budget.

# Actor input Schema

## `keywords` (type: `array`):

Match any phrase across trade/generic name, applicant, supplement reason and approval statement.

## `applicants` (type: `array`):

Restrict results to one or more device applicants.

## `productCodes` (type: `array`):

Restrict results to FDA product codes.

## `decisionDateFrom` (type: `string`):

Inclusive YYYY-MM-DD lower bound.

## `decisionDateTo` (type: `string`):

Inclusive YYYY-MM-DD upper bound.

## `recordKinds` (type: `array`):

Choose original approvals and/or supplements.

## `onlyApproved` (type: `boolean`):

Keep APPR and accepted 30-day notice decisions.

## `minimumMateriality` (type: `string`):

Filter supplements by deterministic business/regulatory materiality.

## `maxItems` (type: `integer`):

Maximum PMA decisions to store.

## Actor input object example

```json
{
  "keywords": [],
  "applicants": [],
  "productCodes": [],
  "decisionDateFrom": "2026-08-01",
  "decisionDateTo": "2026-08-31",
  "recordKinds": [
    "original",
    "supplement"
  ],
  "onlyApproved": true,
  "minimumMateriality": "all",
  "maxItems": 100
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {};

// Run the Actor and wait for it to finish
const run = await client.actor("snuggly_beanie_970/fda-pma-supplement-change-intelligence").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {}

# Run the Actor and wait for it to finish
run = client.actor("snuggly_beanie_970/fda-pma-supplement-change-intelligence").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{}' |
apify call snuggly_beanie_970/fda-pma-supplement-change-intelligence --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,snuggly_beanie_970/fda-pma-supplement-change-intelligence"
        }
    }
}

```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/BEYqKOjtIQQIosiRv/builds/FhBUbCfvMhR5qRIJU/openapi.json