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🫀 FDA PMA Approval & Supplement Change Intelligence

Try for free

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

Pricing

from $4.00 / 1,000 enriched fda pma decisions

Rating

0.0

(0)

Developer

Ilia

Actor stats

Bookmarked

Total users

Monthly active users

3 days ago

Last modified

📤 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:

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.

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