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Introduction:
The FDA mandates the “Annual Establishment Registration Renewal” to oversee medical device manufacturers and maintain accurate records of those involved in producing, packaging, or distributing devices for human use in the United States. This process safeguards public health by ensuring all establishments comply with regulatory standards. Each year, registered establishments must renew their registration to confirm adherence to FDA requirements, enabling the agency to monitor device safety and effectiveness. Let's delve into the details of what this renewal entails and why it's important.
What is Annual Establishment Registration Renewal?
Establishment Registration is the procedure by which companies that manufacture or distribute medical devices register their establishments with the FDA to have their information verified. This procedure is known as Annual Establishment Registration Renewal when it is carried out annually. This renewal, which is mandated by 21 CFR Part 807, guarantees the FDA's ability to monitor and track establishments and the medical devices they manage. It applies to both domestic and foreign companies operating in the U.S. market. This registration is vital as it provides the FDA with critical information about these businesses, enabling effective oversight and regulation.
Annual Registration Renewal: What Does It Involve?
- Renewal Window: Medical device establishments must renew their FDA registrations annually between October 1st and December 31st. Missing the deadline may result in noncompliance, risking their ability to operate in the U.S. market.
- FDA User Fees: Medical device establishments must pay an annual FDA registration fee, set at a flat rate each fiscal year. Unlike submission or approval fees, this fee applies uniformly to all establishments without any waiver.
- Who Must Renew? registration renewal is required for:
- Manufacturers
- Initial Importers
- Distributors
- Contract manufacturer
- Contract Sterilizer
- Relabeler or Repackager
- Remanufacturer
- Reprocessor of single-use devices
- Specification Developer
- Electronic Registration: The registration process is conducted electronically via the FDA’s Unified Registration and Listing System (FURLS) and FDA User Fee account, enabling companies to manage their registration and listing details efficiently.
- Compliance & Enforcement: Failure to renew on time may result in regulatory actions, including import detentions, and marketplace bans.
Annual Establishment Registration Renewal is crucial for FDA compliance and plays a vital role in ensuring the safety and effectiveness of medical devices. By renewing annually and paying the required fees, establishments help support the FDA’s mission to protect public health. Mark the renewal period on your calendar to maintain compliance and uphold your standing with the FDA.
Need guidance? Freyr is here to help you navigate the registration and renewal process with ease. Contact us today for expert support and seamless compliance!