US Representation Services and Options

FDA US Agent Service

Americas Actual US Agent Fee: $750

Foreign manufacturers must identify a US Agent to manage communication with the FDA and be listed on their Establishment Registration form. As required, Americas Actual will maintain a place of business in the US (PO boxes not permitted) and remain available to answer the phone during normal business hours. Activities include answering questions from the FDA on imported devices or assisting in scheduling inspections.

FDA Establishment Registration and Product Listing

FDA Fee: $5,236

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the US are required to register annually with the FDA. This process is known as establishment registration. Americas Actual will manage the payment, registration and listing process on behalf of clients for US Agent services.

Initial Importer Service

The FDA requires all foreign medical device manufacturers to appoint a registered FDA Initial Importer during device registration. With an office in the United States, we can further the marketing of your device, from manufacturer to final sale. Marketing in the United States will often include multiple distributors and sales representatives. Most distributors and sales reps do not want to get involved or register with the FDA. As Initial Importers, we are subject to FDA inspection and are responsible for reporting adverse events to both you and the FDA.

As your Initial Importer, we will:

• Facilitate the marketing of your Class I and/or Class II devices from export to the person who makes final delivery or sale;

• Report adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations), specific malfunctions, Corrections and Removals, and Medical Device Tracking (if applicable);

• Maintain an MDR event file for each adverse event.

Americas Actual can provide Initial Importer support for an annual fee.