Scope of Exemption
According to the general rules, all medical devices should be subject to obligatory premarket notification performed by the manufacturer or its authorized representative in order to be allowed to be placed on the US market. At the same time, the agency explicitly exempts certain medical devices from the requirement regarding the notification procedure. According to the updated list, almost all devices classified as Class I medical devices in accordance with the risk-based classification system are exempt from premarket notification requirements. The scope of exemption also covers devices from the generic category of devices directly indicated as exempted ones. Thus, the manufacturer is not required to submit a 510(k) notification before supplying the devices on the US domestic market. At the same time, it is still necessary to register an establishment and to provide information regarding the classification and generic category.
The devices included in the scope of the exemption from the premarket notification requirement are also exempt from the Good Manufacturing Practice (GMP) requirements except for cases where it is explicitly required by applicable regulations. The GMP requirements are used by the agency to ensure the safety and performance of medical devices present on the US market. Actually, the GMP requirements constitute the minimum requirements for all manufacturing processes, including design, development, production and packaging. The Good Manufacturing Practice requirements also cover subjects related to facilities performing the appropriate operations with medical devices and control measures utilized on all steps of the manufacturing process to ensure the safety and quality of medical devices. Each time reviewing a new application, the FDA assesses whether the manufacturer complies with the appropriate GMP requirements.
Class II Medical Devices Exemption
Besides low-risk Class I medical devices subject to simplified registration procedure in most of the countries, the FDA also extends the exemption provision on certain Class II medical devices. According to the information published by the agency, this approach would allow the FDA to spend less efforts on operations related to such devices and focus on the more significant aspects. At the same time, it is important to mention that despite the exemption from premarket notification, such Class II medical devices still remain subject to GMP requirements.
Registration and Listing Requirements
According to the Food and Drug Administration Amendments Act (FDAAA), the manufacturers and/or their authorized representatives should submit all the information regarding devices in electronic form. In accordance with the official guidance on registration and listing, the whole procedure includes three main steps:
- Payment of the annual registration user fee,
- Information submission performed using a special electronic form,
- Confirmation from the agency regarding compliance with all applicable requirements.
The annual registration fee could be paid using the appropriate website – the Device Facility User Fee (DFUF). Upon making payment using the aforementioned website, an applicant receives the Payment Identification Number (PIN). After the payment has been processed, an applicant would also receive the Payment Confirmation Number (PCN) that could be used to confirm that the obligation on payment has been duly performed. As it is stated in the official guidance, the whole procedure could take a few days, so the agency recommends to initiate payments in advance to have enough time before registering the device.
The registration information about the facility should be submitted through the special online system – Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM). An applicant should have their own ID and password in order to utilize the system. If an applicant appoints a representative to act on its behalf, it would be necessary to create a subaccount. Each entity should have one FURLS account that could be used multiple times to register medical devices. As it is stated in the official guidance, it is required to perform all registrations made by the particular entity using the same FURLS account to retain access to previous registrations (such access would be lost in case of creating a new FURLS account). The account holder will be able to download information uploaded to the system in case it is necessary to provide it during the importation procedure when the manufacturer should provide its identification number and the listing number of the medical device.
It is also important to mention that there are different types of FURLS account depending on the particular role the entity acts as, namely:
- Owner/Operator account – main official account of the entity responsible for all registration procedures. Holders of such an account may create additional subaccounts for its authorized representatives. An account of this type also allows to create new registrations and listings; amend, change or withdraw existing ones and access the information uploaded to the system in the course of registration procedures.
- Official Correspondent – a representative authorized by the owner/operator to perform the procedures related to registration and listing. Such a representative also communicates with the regulating authority and receives all communications from the FDA. This type of account allows the creation of new registrations and listings; amend, change or withdraw listings and access the information uploaded to the system using that account.
To summarize the information provided above, it is important to mention that almost all procedures related to registration and listing medical devices could be performed online using special FDA’s systems. The agency intends to reduce the scope of paper applications to the lowest extent possible to simplify and accelerate all registration procedures.
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Sources:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list
