Medical Devices; Exemptions From Premarket Notification: Class I Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the class I devices included in this document. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

FOR FURTHER INFORMATION CONTACT:

Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: Gregory.Bennett@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.

Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices), are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “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.

The 21st Century Cures Act (Pub. L. 114-255) was signed into law on December 13, 2016. Section 3054 of that Act amended section 510(l) of the FD&C Act. As amended, section 510(l)(2) of the FD&C Act requires FDA to identify through publication in the Federal Register, any type of class I device that the Agency determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA is required to publish this determination within 120 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Section 510(l)(2) further provides that upon the date of publication of the Agency's determination in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. In a final action, FDA intends to amend the codified language for each listed classification regulation to reflect the final determination with respect to 510(k) exemption. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in 510(k) submissions for certain class I devices, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.

II. Criteria for Exemption

As stated previously, section 3054 of the 21st Century Cures Act amended section 510(l) of the FD&C Act. In doing so, the amendments reorganized section 510(l) into subsections 510(l)(1) and (2). As such, subsection 510(l)(1) provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury (hereafter “reserved criteria”). Based on these reserved criteria, FDA has evaluated all class I devices to determine which device types should be exempt from premarket notification requirements. In developing the list of exempt devices, the Agency considered its experience in reviewing premarket notifications for these devices, focusing on the risk inherent with the device and the disease being treated or diagnosed (e.g., devices with rapidly evolving technology or expansions of intended uses). The Agency also considered the history of adverse event reports under the medical device reporting program for these devices, as well as their history of product recalls. Following these considerations, FDA reached the final determination that the devices listed in table 1 do not meet the reserved criteria in that they are not intended for a use that is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury.

III. Limitations on Exemptions

FDA believes that the types of class I devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.

In addition to being subject to the general limitations to the exemptions found in 21 CFR 862.9, 864.9, 866.9, 872.9, 876.9, 878.9, 880.9, 882.9, 884.9 and 886.9, FDA may also partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA lists the exemption of the ataxiagraph device as 510(k) exempt, but limits the exemption to such devices that do not provide an interpretation or a clinical implication of the measurement. All other ataxiagraph devices are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.

IV. List of Class I Devices

FDA is identifying the following list of class I devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions: