Introduction:
Medical device companies aiming to enter the U.S. market must go through a series of regulatory steps. At the core of these is FDA Device Registration, a process that not only legitimizes the business operation but also forms the basis for FDA oversight. With the UDI rule now in effect, registration is more comprehensive and essential than ever before.
Why is FDA Device Registration Required?
The FDA uses the registration database to maintain control over which devices are being sold and by whom. FDA Device Registration is critical for manufacturers, as it ensures compliance with U.S. federal law. Without it, a medical device cannot be legally sold or distributed within the country.
Integrating UDI with FDA Registration
The UDI system is now an integral part of the FDA’s regulatory framework. Labelers must include a UDI on device labels and packages, linking each product to a centralized database. This enhances the visibility of medical devices throughout their lifecycle and supports post-market surveillance. As part of the FDA Device Registration process, manufacturers must list all devices with their corresponding UDI, ensuring seamless tracking and improved patient safety.
Conclusion:
For any medical device manufacturer targeting the U.S. market, FDA Device Registration is a non-negotiable requirement. The addition of UDI to this process ensures a higher level of control, traceability, and safety for both regulators and end-users. It’s a proactive step that demonstrates a company’s commitment to quality and compliance.