SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act).

Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions FDA (the Agency) deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).

Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).

Under section 510(k) of the FD&C Act and FDA's implementing regulations in part 807 of Title 21 of the Code of Federal Regulations (CFR), subpart E (21 CFR part 807, subpart E), persons who are required to register and who propose to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use are required to submit a premarket notification (510(k)) to FDA. The device may not be marketed until FDA finds it “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. A premarket notification is not required for devices in certain situations, such as when they have been exempted from that requirement under section 510(m) of the FD&C Act.

The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law on December 13, 2016. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires that within 90 days of the date of enactment of the Cures Act, and at least once every 5 years thereafter (as FDA determines appropriate), FDA publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. After providing at least a 60-day public comment period, FDA must then publish in the Federal Register a list representing the final determination with respect to the devices contained in the list under section 510(m)(1)(B). Additionally, section 510(m)(2) of the FD&C Act provides that FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act, upon FDA's own initiative or a petition of an interested person, if FDA determines that a report under section 510(k) is not necessary to assure the safety and effectiveness of the device. FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment. Within 120 days after the issuance of this notice, FDA must publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice. ( printed page 23429)

Exemptions from premarket notification for certain clinical toxicology test systems falling within the regulations identified in the instant notice,^[1] in addition to exemptions for other device types, were proposed and finalized in 2017. FDA published its initial notice for these clinical toxicology test systems under section 510(m)(1)(A) of the FD&C Act in the Federal Register of March 14, 2017 (82 FR 13609), and issued its final determination of exemption of the devices in a notice in accordance with section 510(m)(1)(B) of the FD&C Act in the Federal Register of July 11, 2017 (82 FR 31976). In the Federal Register of December 30, 2019 (84 FR 71794), FDA amended the relevant sections of the CFR to reflect the exemptions finalized in July 2017.

FDA is now publishing this notice to announce its intent to expand the 510(k) exemptions in the classification regulations included in this notice to additional devices within the device types, and to request public comment, in accordance with section 510(m)(2) of the FD&C Act. If finalized, the expansion of these exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. Specifically, regulated industry will no longer have to invest time and resources in 510(k) submissions for devices exempt from such requirements.

II. Factors FDA Generally Considers for Exemption

There are a number of factors FDA generally considers to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, titled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary or if an exemption would be appropriate for class II devices: (1) the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices from the 510(k) requirements, these devices would still be subject to general limitations of exemptions. FDA's determinations that premarket notification is not necessary to provide a reasonable assurance of safety and effectiveness for class II devices are often based on the Agency's knowledge of the devices, 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, as discussed in section III of this notice.

III. Limitations of Exemptions

A. General Limitations of Exemptions

FDA's exemptions from premarket notification requirements for the class II device types listed in table 1 apply only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostics, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality (see § 862.9 (21 CFR 862.9) (titled “Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)”). Thus, a manufacturer of a device listed in this document will still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into interstate commerce for commercial distribution when the device exceeds any of the limitations of exemptions described in § 862.9.

B. Partial Limitations of Exemptions

In addition to the general limitations described in section III.A of this notice, partial limitations may limit an exemption from premarket notification requirements to specific devices within a device type.

Currently, the classification regulations included in this notice already include an exemption from 510(k) requirements (subject to the general limitations in § 862.9 as discussed in section III.A of this notice) “provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing,” and as long as the device is not intended for use in Federal drug testing programs.^[2] In this notice, FDA is announcing its intent to remove the exception to the 510(k) exemption for devices intended for Federal drug testing programs. As such, under the proposal, devices in the device types listed in table 1 would be exempt from 510(k) requirements even if intended for use in Federal drug testing programs as long as they do not exceed any of the general limitations of exemptions in § 862.9, and provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, as described in table 1.

When FDA finalized the partial exemptions from 510(k) requirements that are currently included in the classification regulations listed in table 1, FDA assigned new product codes to ensure that exempt and non-exempt devices within a device type would have separate product codes (82 FR 31976 at 31977). If the proposed expansion of the 510(k) exemptions described in this notice is finalized, FDA will continue to use the previously established product codes; however, the definitions of the product codes for exempt devices will be modified to accurately reflect the scope of the exemption,^[3] and devices which are newly exempt will change from a non-exempt product code to the corresponding exempt product code.

IV. List of Class II Devices

FDA has made an initial determination that premarket notification is no longer necessary to provide a reasonable assurance of safety and effectiveness for these devices when they are intended for Federal drug testing programs (see “Proposed Partial Limitations” listed in table 1 of this notice). If the proposed expansion of the 510(k) exemptions described in this ( printed page 23430) notice is finalized, devices in the device types listed in table 1 would not require premarket notification under section 510(k) of the FD&C Act when they are intended for Federal drug testing programs, so long as they do not exceed the proposed partial limitations of exemptions specified in table 1 and the corresponding general limitations of exemptions described in section III.A of this notice.

V. Paperwork Reduction Act of 1995

While this notice contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120.

VI. Reference

The following reference is on display at the Dockets Management Staff (see ADDRESSES ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. Although FDA verified the website address in this document, please note that websites are subject to change over time.

1. FDA Guidance, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at https://www.fda.gov/​media/​72685/​download.

91 FR 23427