Steps to sell in the US
US Agent guide as per FDA
Having a regulatory strategy for the determination of the FDA path (510(k), PMS, de novo) is the first step to marketing medical devices in the USA market. Our team of expert consultants in medical device and USA - FDA regulations will guide you in this process. Contact us to act as your FDA US Agent and provide you with the full service.
Gain the FDA clearance
Manufacturers need to gain the FDA clearance for all medical devices and IVDs before the products can be sold in the USA.
Appoint an US Agent
Non USA-Manufacturers must appoint an FDA-US Agent.
Register Company and Devices
Your company and devices must be registered in the FDA database, the by the Establishment Registration and Device Listing. The US Agent must be able to help you.
Appoint an Initial Importer
For selling your devices in the USA, it is mandatory to have an initial importer when you are not a USA-manufacturer.
Importers shall be identify in the medical devices documentation and in the Device Registration.
US Agent services for medical devices
AF Pharma, a reputable company serving as the US Agent, plays a vital role in assisting medical device manufacturers in navigating the complex landscape of FDA regulations. With our extensive experience and expertise, we specialize in generating essential FDA documents, including 510(k) submissions, to ensure a smooth and efficient pathway for your medical device's entry into the US market. As a manufacturer, understanding the regulatory strategy required by the FDA is crucial when it comes to marketing medical devices in the USA. With AF Pharma as your trusted partner, you can rest assured that our team of expert consultants in medical devices and USA-FDA regulations will guide you through every step of the process.
We recognize that determining the appropriate FDA pathway, whether it be through the 510(k) clearance process, Post-Market Surveillance (PMS) requirements. Or even the innovative de novo pathway, is the first and critical step towards achieving regulatory compliance. Our consultants will work closely with you to assess your device's characteristics, intended use, and risk profile, enabling us to formulate a comprehensive regulatory strategy tailored to your specific needs.
When it comes to generating the necessary FDA documents, such as the 510(k) submission, we have an in-depth understanding of the requirements and can provide the necessary expertise to compile a comprehensive and compelling submission. Our team is well-versed in the FDA's expectations, including the clinical data, performance testing, and risk assessment necessary for a successful application. In addition to our expertise in the 510(k) process, we can also assist you in navigating other regulatory pathways, such as the de novo process for novel devices or PMS requirements for post-market surveillance. Our consultants will assess the unique characteristics of your device and advise you on the most appropriate regulatory pathway, ensuring compliance with FDA regulations while maximizing your chances of successful market entry.
At AF Pharma, we are dedicated to providing exceptional regulatory consulting services, supporting you throughout the entire FDA clearance process. Our goal is to streamline your regulatory journey, saving you time and resources while ensuring compliance and market success. Trust us to be your reliable partner as you bring your medical device to the thriving US market.