What Is FDA Medical Device Establishment Registration
FDA Medical Device Establishment Registration is a mandatory process for companies involved in the production, distribution, or importation of medical devices in the United States. This registration ensures that manufacturers and facilities are listed with the Food and Drug Administration, allowing proper oversight and compliance with federal regulations. It applies to both domestic and foreign establishments that handle medical devices intended for the U.S. market.
Who Needs To Register
Any company that manufactures, repackages, relabels, or imports medical devices into the United States must complete FDA establishment registration. This requirement extends to contract manufacturers, specification developers, and importers. The process helps the FDA monitor the supply chain and ensures that only safe and approved devices reach healthcare providers and patients. Failure to register may lead to serious penalties, import refusals, or restricted market access.
The Registration Process
The FDA requires FDA Medical Device Establishment Registration register annually through its online system known as FURLS (FDA Unified Registration and Listing System). During registration, companies must provide detailed information about their business, device activities, and U.S. agent if located abroad. In many cases, payment of an annual registration fee is required. After submission, the FDA maintains the establishment’s details in its database for public access.
Compliance And Device Listing
Alongside establishment registration, medical device companies must also complete device listing. This means identifying and listing all devices manufactured or imported under that establishment. Listing ensures that the FDA has a clear understanding of which devices are available in the market and who is responsible for them. Both registration and listing are vital parts of compliance under the Federal Food Drug and Cosmetic Act.
Why Registration Matters
FDA Medical Device Establishment Registration plays a key role in safeguarding public health. It provides the FDA with a traceable record of medical device companies and their products, ensuring accountability. For businesses, compliance not only builds trust with healthcare providers and patients but also enables smoother operations in the U.S. medical device market.