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US FDA Medical Device Establishment Registration

In the realm of medical device and IVD commercialization within the United States, a critical step for any establishment engaged in production, importation, reprocessing/relabeling, or the development of specifications is to annually register with the esteemed US Food and Drug Administration (FDA). This pivotal process, known as "Establishment Registration," stands distinct from the procedures involved in obtaining 510(k) clearance or PMA approval.

Navigating this intricate process can sometimes prove perplexing, prompting companies to seek adept assistance. Here at AF Pharma, we stand ready to serve as your guiding hand. With our comprehensive expertise and experience, we have successfully facilitated the Establishment Registration for countless medical device enterprises.

Who Should Register with the FDA?

A fundamental principle mandates that those who manufacture, or play a role in the manufacturing of medical devices sold within the US, must initiate this registration. Additionally, if your activities involve processing, such as sterilization, of these devices, you too fall within the ambit of registration requirements. This process is made in the Establishment Registration and Device listing.

Establishment Registration

FDA Establishment Registration refers to the mandatory process by which facilities or establishments that are involved in the production, distribution, importation, or other activities related to regulated products, such as medical devices, drugs, and biologics, formally register with the United States Food and Drug Administration (FDA). This registration is a fundamental regulatory requirement designed to ensure the safety, quality, and compliance of these products before they are made available to the public

Listing Devices and Your Dedicated US Agent

Beyond registration, the FDA necessitates registered entities to list their devices. Our team at AF Pharma not only assists in the seamless establishment registration but also ensures your devices are aptly listed, fostering comprehensive compliance. We are well-versed in the intricate landscape of medical device regulations, enabling you to meet these regulatory obligations seamlessly.

Why Choose AF Pharma?

We understand that the complexities of FDA Establishment Registration can be daunting. That's why we offer an array of services designed to simplify this process for you:

  1. Streamlined Account Setup: For companies new to the US market, we expedite the account setup process within the FURLS system, ensuring a hassle-free initiation.

  2. Facilitated Fee Payment: Our experts handle the payment of requisite fees, an essential step preceding the commencement of the FDA registration process.

  3. Precision and Detail: We meticulously complete the necessary facility details using the information you provide, ensuring accuracy and compliance.

  4. Thorough Device Listing: Leveraging the FDA Device Registration and Listing Module (DRLM), we ensure your devices are comprehensively listed, leaving no room for oversight.

  5. Classification and Product Code Expertise: If you are registering a Class I product for the first time, we offer guidance in assessing classification and selecting the appropriate Product Code. For other instances, where you possess a 510(k) clearance letter, we harmonize your existing regulatory information with the FURLS registration.

  6. US Agent Role: Notably, AF Pharma can also act as your trusted US Agent, streamlining communication and liaison with the FDA, further enhancing your compliance journey.

AF Pharma as US Agent

As a leading partner in the realm of medical device establishment registration and FURLS listing, AF Pharma stands poised to empower your journey. With our unparalleled expertise, we are dedicated to orchestrating a seamless path to FDA compliance, allowing you to focus on what truly matters – advancing groundbreaking healthcare solutions.

Connect with AF Pharma today and embark on a future of regulatory excellence. Your success is our commitment.

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