The FDA may exempt Class I or Class II devices from the requirement to submit a 510(k) premarket notification on its own initiative, or by petition of an interested person. Exemption from 510(k) requirements reduces the regulatory burden on the medical device industry including the time and costs associated with preparation, submission and responding to requests for additional information. This article provides background and resources to help determine if your Class II device qualifies for a 510(k) premarket notification exemption.
On July 22, 2020, the FDA published its latest order in the Federal Register (85 FR 44186) on its final determination to exempt five additional types of Class II medical devices from the requirement for 510(k) premarket notification as mandated by the 21st Century Cures Act. These devices are subject to the general limitations to the exemptions in 21 CFR 884.9, 888.9 and 890.9. In four of the five cases, the FDA has limited the exemption to certain devices within the generic class (partial exemption limitation). As such, these devices have been assigned new product codes to distinguish them from those that are not exempt. This latest list of Class II devices is shown in Table I.
|21 CFR Section||Device Type||Exempt Product Code (New)||Non-exempt Product Code (Existing)||Partial Exemption Limitation|
|884.6120||Accessory, assisted reproduction||QKH||MQG||Exemption is limited to assisted reproduction laminar flow workstations.|
|884.6180||Media, reproductive||QKI||MQL||Exemption is limited to phosphate-buffered saline used for washing, and short-term handling and manipulations of gametes and embryos; culture oil used an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications.|
|888.4505||Instruments designed for press-fit osteochondral implants||N/A||QBO (existing code, all devices now exempt)||N/A|
|890.5360||Interactive rehabilitation exercise devices||QKC||LXJ||Exemption is limited to prescription use only.|
|890.5670||Massager, therapeutic, to internally massage trigger points in the pelvic floor musculature||QKD||OSD||Exemption is limited to prescription use only devices which incorporate a quantitative feedback mechanism and a disposable covering.|
|Table I. Latest list of Class II devices.|
The FDA has also noted that it is revising the name for product code LXJ from “System, Optical Position/Movement Recording” to “Interactive Rehabilitation Exercise Devices” to more accurately describe the device type that the product code represents.
For more information on FDA device classification, the 21st Century Cures Act and the criteria that the FDA uses in their determination for exemption from 510(k) premarket notification requirements, please read on.
The FDA has established classifications for more than 1700 distinct generic types of devices. Their classification system assigns these generic types of devices to one of three regulatory classes based on the level of risk and therefore the amount of regulatory control necessary to provide reasonable assurance of safety and effectiveness (see Table II).
|Class I||Low to moderate||General controls|
|Class II||Moderate to high||General controls and special controls|
|Class III||High||General controls and premarket approval (PMA)|
|Table II. The FDA has established classifications for more than 1700 distinct generic types of devices.|
General controls are regulatory requirements that apply to all medical devices unless exempted by regulations. Special controls are regulatory requirements that pertain to Class II devices. In this case it is assumed that general controls alone are not sufficient to provide reasonable assurance of safety and effectiveness of the device. Special controls are usually device-specific and can include performance standards, special labeling requirements, premarket data requirements, guidelines or other controls. Premarket approval is required for devices intended to support or sustain human life or prevent impairment to human health and when general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device.
The 21st Century Cures Act (Cures Act)
The Cures Act was enacted on December 13, 2016. The purpose of the Cures Act is to accelerate the discovery, development and delivery of new medicines and medical technologies. Under the Cures Act, section 510(m) of the FD&C Act was amended to require the FDA to publish a notice in the Federal Register containing a list of Class I and Class II devices that they have determined to no longer require a 510(k) premarket notification to provide reasonable assurance of safety and effectiveness. The goal is to decrease the regulatory burden and costs on the medical device industry as they will no longer have to invest time and resources in 510(k) notifications.
Within 90 days after the date of enactment, and at least once every five years thereafter, the FDA must publish a notice of intent with a list of devices that the FDA believes no longer require a 510(k) premarket notification. A comment period of at least 60 calendar days must be provided to the public. Within 210 days of enactment, the FDA must publish its first final determination on the devices listed for exemption.
The FDA published its first round of final determinations on exemptions in the Federal Register in 2017:
- 70 Class I devices on April 13, 2017 (82 FR 17841)
- ~1000 Class II devices on July 11, 2017 (82 FR 31976)
In December 2019, they published a final order (84 FR 71794) to amend the codified language used in the classification regulations based on the final determinations. The new list of Class II devices that was published on July 22, 2020 is the second round of final determinations that has come well before the five-year deadline.
Criteria for Exemption and Limitations
The FDA published a Federal Register notice and a guidance document on the criteria for determining whether a 510(k) is necessary to provide reasonable assurance of the safety and efficacy of a Class II device.
In making their determination for exemption, the FDA considers the following factors:
- Whether the device has a significant history of risks associated with inherent characteristics of the device or of false/misleading claims
- Whether characteristics of the device for safe and effective performance are well established
- Whether changes to the device that could affect safety and/or effectiveness would be readily detectable before causing harm (e.g. by routine testing or visual inspection) or increase the risk of ineffective treatment, incorrect diagnosis or injury
- Whether changes to the device would likely result in a change to the device’s classification
It is important to note that all devices classified as exempt are subject to the limitations on exemptions covered under 21 CFR XXX.9 (where XXX refers to Parts 862-892). In addition, the FDA may limit the exemption to certain devices within a generic class (partial exemption limitation). In such cases, new product codes are assigned to separate the exempt devices from those that do not fall within the partial exemption limitations under the existing product code.
Further, devices determined to be exempt from the requirement of 510(k) premarket notification are still subject to other statutory or regulatory requirements (unless such exemption is explicitly provided by order or regulation) as it is assumed that safety and effectiveness, at least in part, is assured by other regulatory controls such as current good manufacturing practice requirements.
It can be determined whether a device is exempt from 510(k) requirements by searching the FDA’s Product Classification Database. Alternatively, there is a listing of exempt devices grouped by panel (21 CFR part 862-892) on the FDA’s website.
Under the Cures Act, the FDA is required to publish lists of Class I and Class II devices that have been determined to be exempt from 510(k) premarket notification requirements at least once every five years. The objective is to reduce the workload for the Agency and decrease the regulatory burden and costs associated with 510(k) notifications for device manufacturers. Use the information provided in this article to guide your research, but check with the FDA or use an accredited consultant to make a final determination for your medical device regulatory strategy.