FDA compliance statement

Last Updated: 30th July 2025

Our FDA Registration

Newfoundland Diagnostics Ltd is registered with the U.S. Food and Drug Administration as a distributor of medical devices.

• FDA Registration Number: 3031231787
• Registration Type: Foreign Private Label Distributor
• Product Category: Over-the-Counter (OTC) In Vitro Diagnostic Devices
• Registered Address: 3a Station Road, Amersham, Buckinghamshire, HP7 0BQ, United Kingdom

What This Means

As an FDA-registered distributor of OTC devices:

• We maintain proper storage and handling procedures
• We ensure product traceability
• We report adverse events to manufacturers and FDA as required
• We distribute only FDA-cleared or approved devices
• We comply with FDA regulations for OTC device distribution

What This Does NOT Mean

• We are not the manufacturer of these devices
• FDA registration is not FDA approval of our company
• We do not modify or repackage the devices
• We cannot make claims beyond those approved for the device

OTC Device Specific Information

Our products are classified as OTC in vitro diagnostic devices, meaning:

• They can be purchased without a prescription
• They are intended for home use by consumers
• They have been authorized by FDA for self-testing
• They do not require CLIA certification for use

Product Complaints and Adverse Events

We maintain complaint files as required by FDA. If you experience:

• Any malfunction that could cause serious injury
• Any adverse reaction to a test
• Any quality issue with a product

Please report it immediately to:

• Us at info@newfoundland.io
• FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088