Introduction
The process of bringing a medical device to market in the United States involves stringent regulations imposed by the Food and Drug Administration (FDA). Understanding the distinction between FDA FURLS (FDA Unified Registration and Listing System), FDA Approved, and FDA Registered is crucial for manufacturers and distributors seeking to comply with these regulations. This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.
Device Registration and Listing Requirements
Since October 1, 2012, specific medical device listing requirements have been in effect. It is imperative for all stakeholders to adhere to these regulations:
- All proprietary names under which a device is marketed must be reported during initial listing and in the annual update of registration and listing information.
- Combination products, which include devices and biological products or drugs, must be clearly identified, specifying the type of combination product, such as convenience kit or prefilled drug delivery device, through the FDA Unified Registration and Listing System (FURLS).
- Regardless of commercial distribution, all contract manufacturers and sterilizers of finished devices are obligated to register and list their products.
- Initial importers must identify the manufacturers of the devices they import.
- Foreign establishments exporting devices to the United States must identify all known U.S. importers of their devices.
- Devices must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or re-packer/re-labeler before a foreign exporter, contract manufacturer, or contract sterilizer can list them.
- Establishments handling complaints, previously registered as manufacturers or specification developers, should update their establishment type to “Complaint File Establishment.”
FDA Approved: Ensuring Safety and Efficacy
FDA approval refers to the process by which a new medical device undergoes rigorous evaluation to ensure its safety and efficacy before it can be marketed in the United States. The approval process involves the submission of a premarket approval (PMA) application or a 510(k) premarket notification, depending on the device’s classification. PMA applications are required for Class III devices, which are high-risk devices such as implantable pacemakers and certain diagnostic imaging devices. 510(k) premarket notifications are for devices that are equivalent to a legally marketed device (predicate device) and are typically lower risk.
FDA Registered: Establishment Compliance
FDA registration is a mandatory requirement for all medical device establishments. It involves providing detailed information about the facility, its operations, and the devices it manufactures, processes, packs, or holds. FDA-registered establishments are subject to inspections to ensure compliance with FDA regulations, including good manufacturing practices (GMP). Registration is a prerequisite for selling medical devices in the U.S. market, and failure to register can lead to serious consequences, including legal actions and fines.
How to Obtain Licenses? Step-by-Step Guide
- Determine Device Classification: Identify the correct classification of your medical device according to the FDA’s classification system (Class I, II, or III).
- Prepare Necessary Documentation: Depending on the device classification, prepare the required documentation, such as a 510(k) premarket notification or a PMA application. Work closely with regulatory experts and consultants to ensure the accuracy and completeness of the submission.
- Submit Application: Submit the application to the FDA along with the required fees. The FDA will review the submission and provide feedback or request additional information if necessary.
- Facility Registration: Concurrently, ensure that your establishment is registered in the FDA FURLS database. Update registration information annually to maintain compliance.
- Quality System Requirements: Implement a quality management system compliant with FDA regulations, including GMP. Prepare for FDA inspections to demonstrate compliance with quality system requirements.
- Post-Market Surveillance: Establish a post-market surveillance system to monitor the performance and safety of your device after it enters the market. Report adverse events and product issues promptly to the FDA.
Conclusion
Navigating the intricate regulatory landscape of medical device approval and registration demands a deep understanding of FDA FURLS, FDA Approved, and FDA Registered designations. By aligning with expert consultants and regulatory professionals, manufacturers and distributors can successfully obtain the necessary licenses, providing safe and effective medical devices to enhance healthcare outcomes for patients across the United States.
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.
