Medical Devices; Exemptions From Premarket Notification: Class II Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, 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 list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.

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, email: Gregory.Bennett@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject to certain limitations. This notice was issued in accordance with the 21st Century Cures Act (Pub. L. 114-255), which was signed into law on December 13, 2016. Section 3054 of that statute amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the 21st Century Cures Act and at least once every 5 years thereafter, FDA must 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 (generally referred to as a premarket notification or “510(k)”) to provide reasonable assurance of safety and effectiveness. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the list of devices proposed in the March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that upon the date that this final list is published in the Federal Register, a 510(k) will no longer be required for the listed devices and the applicable classification regulation for these devices shall be deemed amended to incorporate such exemption. Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. After reviewing these comments and considering whether the proposed list should be modified, FDA is now identifying its final determination as to which of those devices are now exempt from premarket notification requirements, subject to certain limitations, as indicated in tables 1 to 3 of this notice.

In a future action, FDA intends to amend the codified language for each listed device's classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw their submissions.

These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, 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

There are a number of factors FDA may consider 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, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (“Class II 510(k) Exemption Guidance”) (Ref. 1).

III. Limitations on Exemptions

FDA believes that the types of class II 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 Title 21 of the Code of Federal Regulations (CFR) sections 862.9 to 892.9 (§§ 862.9 to 892.9), when Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. 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. Partial exemption limitations can be found in table 2 of this notice. FDA has assigned new product codes to the device types that are now exempt subject to the partial limitations in order 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 will have distinct product codes). If table 2 indicates that a partial exemption limitation does apply to a device, then affected device manufacturers should review their registration and listing information to assess if they should list their device using the original classification product code, which requires premarket notification, or the new classification product code for the subset of that device type that is now 510(k) exempt (subject to the general limitations to the exemptions found in §§ 862.9 to 892.9). In table 2, for example, FDA is listing the exemption of the tympanometer but limits the exemption to such devices that are in compliance with FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply with this partial exemption limitation and the corresponding general limitations in § 874.9 are now exempt from the 510(k) requirements and should be identified under new product code “PTP” in subsequent registration and listing submissions. However, tympanometers not in compliance with each of these exemption limitations remain subject to the 510(k) requirements and will retain product code “NAS.” We recommend that device manufacturers document in their records any changes in the product code of their device with appropriate justification.

IV. List of Class II Devices

In table 1, 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 §§ 862.9 to 892.9:

In table 2, FDA is identifying a 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 §§ 862.9 to 892.9, as well as the indicated partial exemption limitations. Devices listed in table 2 are now exempt, but only if they are in concurrent compliance with both the partial exemption limitation specified in table 2 and its corresponding general limitation found in the .9 section of Parts 862 to 892 of Title 21 of the CFR.

In table 2, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system). FDA does not believe that all devices classified under this regulation meet the exemption criteria from premarket notification requirements. The devices listed in table 3 are also classified under § 866.5750, but this subset no longer requires premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in § 866.9. While the non-exempt devices classified under § 866.5750 will retain product code “DHB”, these devices listed in table 3 are reassigned product code “PUW.”

V. Reference

The following reference is on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 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. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.