FDA Registration and Listing

Registration and listing play a crucial role in ensuring the safety and effectiveness of medical devices in the United States. By providing the Food and Drug Administration (FDA) with information about the location of medical device establishments and the devices manufactured there, we enhance the nation's preparedness for public health emergencies. In this blog post, we will explore the significance of registration and listing and highlight how AF Pharma can serve as your US Agent, streamlining the process for foreign establishments.

Establishment Registration:

Every establishment involved in the design, production, or distribution of medical devices intended for use in the United States must register annually with the FDA. This registration is vital for maintaining transparency and accountability within the industry. Additionally, it incurs an annual establishment registration fee, which contributes to funding regulatory activities. It's important to note that the fee reduction available for companies with an FDA-issued Small Business Determination does not apply to the annual registration fee, as all establishments and facilities pay the identical fee.

Device Listing:

To market medical devices in the US, they must be listed with the FDA in association with a registered establishment. The FDA has categorized establishment types and determined which ones are required to list associated devices and their corresponding activities. For devices that require premarket approval or notification prior to legal marketing, the listing activity necessitates providing the relevant premarket submission number. This step ensures that the FDA has comprehensive knowledge of the devices available in the market and can monitor their safety and efficacy.

U.S. Agent and Official Correspondent:

As a foreign establishment, you are required to identify a United States Agent (U.S. Agent) who will act as your representative. This agent should be located in the US or have a place of business there. AF Pharma is an experienced and reliable US Agent that can fulfill this role effectively. The U.S. Agent's responsibilities include facilitating communication between your company and the FDA. While the U.S. Agent does not bear the responsibility for adverse event reporting or submitting premarket notifications, AF Pharma can assist you with these additional activities outside of the U.S. Agent's scope.

Why Choose AF Pharma as Your US Agent?

AF Pharma offers a range of benefits to foreign establishments seeking a US Agent. Our expertise and knowledge of the FDA regulations ensure that your registration and listing process is efficient and compliant. By appointing AF Pharma as your U.S. Agent, you gain a dedicated partner who will serve as the initial point of contact between your company and the FDA. This relieves you of the administrative burden and allows you to focus on your core business operations.

Registration and listing are vital components of the medical device regulatory landscape in the United States. They enable the FDA to have accurate and up-to-date information about medical device establishments and the devices they produce. AF Pharma, as your US Agent, can streamline this process for you, ensuring compliance and facilitating effective communication with the FDA. By entrusting AF Pharma with your registration and listing requirements, you can navigate the regulatory landscape with confidence, knowing that you have a trusted partner by your side.