🫀 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:

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.