The Federal Trade Commission (FTC)’s Mobile Health App Tool provides broader context, beyond just the U.S. Food and Drug Administration, by helping developers identify which U.S. federal laws may apply to their mobile health app.
The FDA regularly updates its Recognized Consensus Standard database, which can help manufactures establish declarations of conformity with their submission
Before you export your medical device to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
Click here for additional information. You may also use the Live Support Chat for any question, 24/7.
We expect you to provide the following with your payment:
- Full company name, complete physical address (street, city, state, postal code, country)
- Company DUNS Number
- Name, telephone and email of CEO / Manager
- Products details