2017-24163. Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES:

Submit either electronic or written comments on the notice by January 8, 2018.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 8, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-1129 for “Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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, [e-mail].

SUPPLEMENTARY INFORMATION

:

I. Statutory Background

Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a new device to submit and obtain clearance of 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 (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 FDA to 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. FDA is required to publish this notice within 90 days of the date of enactment of the Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. FDA published this notice in the Federal Register of March 14, 2017 (82 FR 13609). Under section 510(m)(1)(B) of the FD&C Act, FDA must publish in the Federal Register, within 210 days of enactment of the Cures Act, a list representing its final determination regarding the exemption of the devices that were contained in the list published under section 510(m)(1)(A). FDA published that list in the Federal Register of July 11, 2017 (82 FR 31976).

As amended, section 510(m)(2) of the FD&C Act provides that, 1 day after the date of publication of the final list under section 510(m)(1), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act upon its 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. To do so, FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-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. If FDA fails to respond to a petition under section 510(m)(2) of the FD&C Act within 180 days of receiving it, the petition shall be deemed granted.

II. Factors FDA May Consider 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). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary 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, these devices would still be subject to the limitations on exemptions.

III. Limitations on Exemptions

FDA has determined that premarket notification is not necessary to assure the 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.

A. General Limitations of Exemptions

FDA's proposal to grant an exemption from premarket notification for 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, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA proposes that 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 862.9 to 21 CFR 892.9.

B. Partial Limitations of Exemptions

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 initial 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. 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 proposed exemption of the genetic health risk assessment system, but limits the exemption to such devices that have received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”). FDA believes that a one-time FDA review (e.g., premarket notification) of a genetic health risk assessment system is necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA believes that a one-time FDA review of a genetic health risk assessment system is necessary to mitigate the risk of false negatives and false positives by ensuring that certain information be submitted to FDA to allow the Agency to assess the safety and effectiveness of the devices and the regulatory controls necessary to address those issues as well as to ensure the devices perform to acceptable standards.

IV. List of Class II Devices

FDA is identifying the following list of class II devices that, if finalized, would 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:

Table 1—Class II Devices

21 CFR section	Device type	Product code	Partial exemption limitation (if applicable)
862.1840	Total 25-hydroxyvitamin D Mass Spectrometry Test System	PSL
866.5950	Genetic Health Risk Assessment System	PTA	Exemption is limited to a genetic health risk assessment system that has received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”).
876.1500	Endoscopic Maintenance System	PUP
880.6710	Purifier, Water, Ultraviolet, Medical	KMG
884.5960	Vibrator for Therapeutic Use, Genital	KXQ

V. Reference

The following reference is on display in 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. 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 https://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​UCM080199.pdf.

Dated: October 31, 2017.

Lauren Silvis,

Chief of Staff.