The Food and Drug Administration (FDA) announced an exemption from premarket notification for certain Class II medical devices.
FDA Exemption in Brief
The FDA has published an order indicating class II medical devices to be exempt from 510(k) premarket notification requirements. The document also outlines certain limitations to be applied with regard to the exemption rule. According to the announcement, the exemption takes effect immediately. The FDA states that these measures have been implemented in order to reduce regulatory burdens and costs associated with achieving and sustaining compliance with the applicable regulations.
The present exemption is based on the Federal Food, Drug, and Cosmetic (FD&C) Act – the main US law that governs the relationships in the sphere of medical devices. The rule on exemption takes effect on July 22, 2020.
Regulatory Background
According to the general rule set forth by section 510(k) of the FD&C Act, any entity that intends to place a medical device on the market shall submit the appropriate application to the regulating authority. Depending on the particular medical device in question, the applicant (medical device manufacturer, its authorized representative, importer, supplier, or any other party) shall either demonstrate the equivalence to another medical device already placed on the market or apply for the FDA-approval.
There are a few exemptions from the aforementioned rule. The 21st Century Cures Act, adopted in 2016, amended the section 510(m) of the FD&C Act, allowing the FDA to introduce special exemptions for certain class II medical devices, if such an exemption is suitable due to the safety and effectiveness aspects associated with the device. If the FDA determines that for certain medical devices such exemption should be applied, they shall follow the procedure as described below:
- Publication of an appropriate notice in the Federal Register,
- Comment period – 60 calendar days – during which the industry representatives may provide their comments and suggestions.
- Publication of the final order in the Federal Register – within 120 days from the date the initial notice has been published.
The FDA is entitled to publish the exemption notice on its own initiative if it finds it reasonably necessary to exempt certain class II medical devices from the 510(k) premarket notification requirement in accordance with the amended provisions of the FD&C Act. In case no comments are received during the appropriate period, the FDA will issue an order containing the final determination regarding the devices to be covered by the scope of the exemption. Such an order becomes effective immediately – the day following the date the order has been published. In this way, the FDA actually amends the appropriate regulations related to the medical devices falling within the scope of the exemption.
Medical Device Eligibility Criteria for Exemption
When making its determination regarding the applicability of the exemption, the FDA considers a wide range of aspects related to the safety and effectiveness of a medical device in question. According to the official announcement, the aforementioned criteria are highlighted in the FDA guidance “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff”, also referred to as the “Class II 510(k) Exemption Guidance.”
According to the aforementioned FDA guidance, when making a determination regarding the applicability of an exemption for the particular class II medical device, the FDA will consider the following factors:
- The device should not have a significant history of false or misleading claims,
- Characteristics of the device necessary for its safe and effective performance,
- Changes in the device that could affect safety and effectiveness should be either easily detectable or not result in a significant increase in the associated risk,
- Any changes to the device should not impact its classification.
If an interested party intends to initiate the exemption, it should provide the FDA with the information covering all the points above – this would allow them to provide a detailed and accurate response.
Limitations on Exemptions
It is also important to mention that there are certain limitations related to the exemptions from 510(k) premarket notification requirements introduced by the FDA. These limitations are actually based on the information the FDA already has regarding the safety and effectiveness aspects associated with class II medical devices. In particular, the Agency outlines the following limitations:
- General Limitations – A class II medical device could be placed on the market under the exemption framework only if it is included in the appropriate list published by the Agency. However, if the device falls within the scope of 21 CFR 884.9, 888.9, and 890.9., the applicant would still have to submit a premarket notification.
- Partial Limitations – In complex cases, the FDA is entitled to limit the scope of application of the exemption for certain medical devices inside of the generally exempted group. According to this rule, the FDA may determine that the exemption either (a) could be applied to certain devices within the group or (b) could not be applied for certain medical devices from the generally exempted group.
Exempted Class II Medical Devices
The final order published by the FDA also contains a list of class II medical devices explicitly exempted from the 510(k) premarket notification requirement. The document also outlines the scope of the application of limitations.
The FDA assigns new product codes to the medical devices falling within the scope of the order. These codes should be used to distinguish medical devices covered by the limitations.
The list of class II medical devices covered by the order includes the following ones:
It is important to mention that for all products (except ones regulated under 21 CFR 888.4505, product code QBO) certain limitations are applicable.
Thus, by implementing the aforementioned rules, the FDA actually amends 21 CFR parts 884, 888, and 890.
Summarizing the information provided hereinabove, the FDA’s final order on class II medical device exemption outlines certain types of medical devices for which the requirement to submit a 510(k) premarket notification should not be applied since it is not reasonably necessary for the Agency to assess the safety and effectiveness issues associated with such devices. The document also describes the particular steps to be taken by the Agency in order to add new devices to the scope of the exemption. In particular, the FDA shall publish an initial notice in the Federal Register, accept public comments within 60 days, and then publish an order containing the final determination and the list of exempted class II medical devices.
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