The US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification requirements, and has proposed similar exemptions for several other device types to expand access to these products during the COVID-19 public health emergency.
Making permanent regulatory flexibilities provided during the COVID-19 public health emergency by exempting certain medical devices from premarket notification requirements; Request for information, Research, Analysis and Public comment on opportunities for further science and evidence-based reform of section 510(k) program.
To provide Americans with expanded access to certain medical devices to respond to the COVID-19 public health emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premmarket notification requirements under section 510(k) of the Food, Drug and Cosmetic Act. For seven class I devices for which 510(k) premarket review as temporarily waived during the PHE, the Department of Health and Human Services is permanently exempting those seven class I devices from the 510(k) requirement, include surgical and examination gloves; these exemption took effect Janurary 15, 2021; and is also proposing to exempt an additional 83 class II devices and 1 unclassified device class from the 510(k) requirement, for which premarket review had also been waived during the PHE. The department is soliciting the public's views on whether premarket review should be permanently waived for some or all of these 83 devices and views on ways to improve thhe 510(k) premarket notification program.
Class II devices and Unclassified devices by the permanent 510(k) exemption proposal include a wide range of products and systems; home-use ventilators, airway monitoring systems, OTC electrocardiograph software, air purifiers and cleaners, medical device cleaners, N95 respirators and oxygenators. · Table 6 of the FDA notice provides a full list of Class II and unclassified devices identified for exemption.
Table 6—Class II Devices and Unclassified Devices Proposed Exempt from 510(k) Requirement
Other devices exempted for 510(k)
FDA has determined that premarket notification is not necessary to provide a reasonable assurance of safety and effectiveness of the class II devices listed in table 1. This determination is based, in part, on the Agency's knowledge of the device, including past experience and relevant reports or studies on device performance (as appropriate), the applicability of general and special controls, and the Agency's ability to limit an exemption.
FDA's exemption from premarket notification for the class II devices listed in table 1 applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type. A manufacturer of a listed device would still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in 21 CFR 884.9, 888.9, and 890.9.
In addition to the general limitations, FDA may also partially limit an exemption from premarket notification requirements to specific devices within a listed device type when an initial Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance do not weigh in favor of exemption for all devices in a particular group. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. In table 1, for example, FDA is listing the exemption of the optical position/movement recording system but limits the exemption to such devices that are for prescription use only. FDA believes that premarket review (e.g., premarket notification) of an optical position/movement recording system for over-the-counter (OTC) use is necessary to ensure that the exercises and activities led by the system are appropriate for a user's rehabilitation and to assess the measurement accuracy of the system. Additionally, a therapeutic massager to internally massage trigger points in the pelvic floor musculature would exceed the exemption limitation and would require 510(k) review if it is indicated for OTC use, lacks a quantitative feedback mechanism, or lacks a disposable covering.
In this final order, FDA is identifying the following list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in 21 CFR 884.9, 888.9, and 890.9 and any partial exemption limitations identified in Table 1.
FDA assigned new product codes to the device types that are exempt subject to the partial limitations to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code (i.e., exempt and non-exempt devices within a device type now have distinct product codes).
Table 1: The list of class II device that no longer requires 510k, but if the product meets any conditions in 21 CFR 884.9, 888.9, and 890.9, it would be required to submit 510k.
Source:
Contact us at: info@arqon.com