[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25910-25915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 866, 876, 880, and 884

[Docket No. FDA-2017-N-1129]


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
publishing an order to exempt a list of class II devices from premarket 
notification (510(k)) requirements, subject to certain limitations. 
This exemption from 510(k), subject to certain limitations, is 
immediately in effect for the listed class II devices. This exemption 
will decrease regulatory burdens on the medical device industry and 
will eliminate private costs and expenditures required to comply with 
certain Federal regulations. FDA is also amending the codified language 
for the listed class II devices to reflect this final determination. 
FDA is publishing this order in accordance with the section of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the 
exemption of a device from the requirement to submit a 510(k).

DATES: This order is effective June 5, 2018.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices 
and

[[Page 25911]]

Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 66, Rm. 4676, Silver Spring, MD 20993-0002, 301-
796-6217.

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 (21 U.S.C. 
360c(i)) to a legally marketed device that does not require premarket 
approval.
    On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. 
L. 114-255) was signed into law. Section 3054 of the Cures Act amended 
section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides 
that, 1 calendar day after the date of publication of the final list 
under section 510(1)(B), 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 510(k) is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. This section 
requires FDA to publish in the Federal Register a notice of intent to 
exempt a device, or of the petition, and provide a 60-calendar-day 
comment period. Within 120 days of publication of such notice, FDA 
shall 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.

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''). That guidance can be obtained through the 
internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by 
sending an email request to CDRH-Guidance@fda.hhs.gov to receive a copy 
of the document. Please use the document number 159 to identify the 
guidance you are requesting.
    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. Comments on the Proposed Exemption and FDA Response

    In the Federal Register of November 7, 2017 (82 FR 51633), FDA 
published a notice (``November 2017 notice'') announcing its intent to 
exempt, upon its own initiative, certain class II devices listed in 
table 1 from 510(k) requirements, subject to certain limitations, and 
provided opportunity for interested persons to submit comments by 
January 8, 2018. After reviewing comments received, FDA is now 
providing its final determination on exempting the certain class II 
devices listed in table 1 from 510(k) requirements, subject to certain 
limitations as identified in this order. FDA is also amending the 
codified language for the classification regulations for the certain 
class II devices listed in table 1 to reflect this final determination. 
Persons with pending 510(k) submissions for devices that are now exempt 
from 510(k), subject to the limitations, should withdraw their 
submissions.
    In response to the November 2017 notice announcing FDA's intent to 
exempt those device types from 510(k) requirements, FDA received a 
submission from one commenter--a professional organization--opposing an 
exemption from 510(k) for the genetic health risk assessment test 
device type.
    To make it easier to identify comments and our responses, the word 
``Comment'' appears in parentheses before the comment's description, 
and the word ``Response'' in parentheses precedes the response. 
Specific issues raised by the comment and the Agency's response 
follows.
    (Comment) The commenter recommended FDA not exempt one-time FDA 
reviewed genetic health risk assessment system devices from the 510(k) 
requirement because there would be insufficient oversight to ensure the 
analytical and clinical validity of these tests, consumers would be 
misled regarding which tests FDA has affirmed are scientifically valid, 
and concerns that, if one-time FDA reviewed genetic health risk 
assessment system devices were exempted, consumers would not be assured 
of being adequately informed about test quality. The commenter believed 
it is not possible to assess the analytical and clinical validity of 
all genetic health risks a company might offer by conducting a one-time 
review of its `assessment system', as proposed by FDA. Such oversight, 
it is argued, will only allow FDA to assess the analytical and clinical 
validity, and `mitigate the risks of false negatives and positives', 
for tests initially proposed by the company during this one-time 
review. The commenter believed that it does not appear that there will 
be assessment of the analytical or clinical validity of subsequent 
tests offered, nor any assessment of the risks to the consumer of an 
incorrect result. This commenter believed that FDA's proposal to exempt 
one-time FDA reviewed genetic health risk assessment system devices 
will not prevent scientifically invalid tests from being marketed to 
the public and lacks a comprehensive assessment. Further, the commenter 
argued that, after undergoing the one-time FDA review for genetic 
health risk assessment tests, companies would be able to market 
subsequent tests to the public as part of the same system and declare 
that the tests meet FDA's standards. Such tests would not be held to 
any specific standards of analytical or clinical validity. The public 
would likely assume (and purveyors would likely advertise) that FDA had 
reviewed and approved such tests as valid even though they had not been 
reviewed by the Agency. The commenter also argued that there is a vast 
range of quality (i.e., scientific merit) of direct-to-consumer (DTC) 
genetic health risk assessment tests on the market. The commenter 
argued that the market's current mixing of entertainment tests, which 
make claims unsubstantiated by the scientific literature, with those 
tests which have a clinical utility, are clinically valid, and can be 
supported by current scientific

[[Page 25912]]

literature, is particularly confusing for the average consumer.
    (Response) We agree that the concerns raised above are important. 
These concerns were considered during our review and development of the 
initial classification regulation for genetic health risk assessment 
system devices and in our consideration of whether to exempt one-time 
FDA reviewed genetic health risk assessment system devices from the 
510(k) requirement. We believe these concerns have been addressed and 
accounted for in our determination that the 510(k) requirement is not 
necessary to provide a reasonable assurance of safety and effectiveness 
for these devices. We outline our rationale below.
    Consumer understanding of genetic risk is clearly an important 
issue that was considered extensively by FDA in the context of genetic 
health risk assessment system devices. This issue was balanced with the 
increasing desire from the public to learn more about one's own genetic 
makeup and how it affects genetic risk for health conditions. To ensure 
that the tests and test reports are presented to the lay consumer in a 
manner that is understandable, we employed several requirements. 
Consumer understanding of the tests and associated test reports is 
assured by user comprehension study requirements, specific labeling 
requirements for these over-the-counter (OTC) tests, and general 
requirements for devices. The special labeling requirements for these 
devices under Sec.  866.5950(b) (21 CFR 866.5950(b)) include providing 
information on the manufacturer's website about frequently asked 
questions, available professional guidelines, and how to obtain access 
to a genetic counselor.

A. User Comprehension Study

    A user comprehension study is required under Sec.  
866.5950(b)(3)(iii)(M). The required user comprehension study must 
assess comprehension of the test process and results by potential users 
of the test with pre- and post-test user comprehension studies. This 
study must be conducted on a statistically sufficient sample size of 
non-trained individuals who represent the demographics of the United 
States as well as a diverse range of age and educational levels. The 
study must include directly evaluating a representative sample of the 
material being presented to the user during use of the test. The test 
that is given to the participants must be informed by a physician and/
or genetic counselor that identifies the appropriate general and 
variant-specific concepts contained within the material being tested in 
the user comprehension study to ensure that all relevant concepts are 
incorporated in the study as well as having included the definition of 
the target condition being tested and related symptoms, explain the 
intended use and limitations of the test, explain the relevant 
ethnicities in regard to the variant tested, explain genetic health 
risks and relevance to the user's ethnicity, and assess participants' 
ability to understand the following comprehension concepts: The test's 
limitations, purpose, appropriate action, test results, and other 
factors that may have an impact on the test results. The outcome of 
this study has to meet rigorous standards, including meeting predefined 
primary endpoint criteria, including a minimum of a 90 percent or 
greater overall comprehension rate (i.e., selection of the correct 
answer) for each comprehension concept. In addition, the testing must 
follow a format where users have limited time to complete the studies 
(such as an onsite survey format and a one-time visit with a cap on the 
maximum amount of time that a participant has to complete the tests). 
From our experience with user comprehension studies, the Agency 
believes that meeting or exceeding these user comprehension study 
requirements ensures that the materials presented to the user are 
adequate for OTC use. The information the test provider must provide on 
its website includes a summary table of comprehension rates regarding 
comprehension concepts (e.g., purpose of test, test results, test 
limitations, ethnicity relevance for the test results, etc.) for each 
study report.

B. Frequently Asked Questions

    The manufacturer's website must have a frequently asked questions 
section in the summary and technical information sections under Sec.  
866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). For the frequently 
asked questions sections, information must be included that is specific 
for each variant/disease pair that is reported and scientifically valid 
and supported by corresponding publications. Further information must 
be included that explains the health condition/disease being tested, 
the purpose of the test, the information the test will and will not 
provide, the relevance of race and ethnicity on the test results, 
information about the population to which the variants in the test is 
most applicable, the meaning of the result(s), other risks factors that 
contribute to disease, appropriate followup procedures, how the results 
of the test may affect the user's family, including children, and links 
to resources that provide additional information.

C. Resources

    Likely the test labeling information provided by the test 
manufacturer will not be the sole source of information that the 
consumer is seeking or even requires. For this reason, there are 
requirements under Sec.  866.5950(b)(3)(ii)(C)(2) and (b)(3)(iii)(L)(2) 
that the manufacturer of the test provide a pre-purchase page in the 
summary and technical information sections that includes information 
regarding professional guidelines for testing specific genes and 
variants. Similar information must be provided in the frequently asked 
questions section found in the summary and technical information 
sections on the manufacturer's website, under Sec.  
866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). These frequently asked 
questions sections must include a statement about the current 
professional guidelines for testing these specific gene(s) and 
variant(s) and, if guidelines do not exist for certain genes or 
variants being tested for, then this information must be provided as 
well. Further, to facilitate more personalized support, under Sec.  
866.5950(b)(1)(i)(E), test manufacturers are required to provide 
information in the Sec.  809.10 (21 CFR 809.10) compliant labeling and 
any pre-purchase page and test report generated regarding how a user 
obtains access to a genetic counselor, board-certified clinical 
molecular geneticist, or equivalent healthcare professional regarding 
the results of a user's test.

D. Genetic Health Risk Assessment System Tests

    The tests that fall under the genetic health risk assessment system 
regulation are identified in the regulation in Sec.  866.5950(a) as a 
qualitative in vitro molecular diagnostic system used for detecting 
variants in genomic deoxyribonucleic acid (DNA) isolated from human 
specimens that will provide information to users about their genetic 
risk of developing a disease to inform lifestyle choices and/or 
conversations with a healthcare professional. This assessment system is 
for OTC use. This device does not determine the person's overall risk 
of developing a disease.
    The limitations that are most important for lay users to know about 
the intended use of these tests that fall under this device type are 
conveyed via the limiting statements required, under Sec.  
866.5950(b)(1)(i), to be provided on the Sec.  809.10 compliant 
labeling and any pre-purchase page and test report generated. One of 
these limiting statements must explain that this test is

[[Page 25913]]

not intended to diagnose a disease, tell you anything about your 
current state of health, or be used to make medical decisions, 
including whether or not you should take a medication or how much of a 
medication you should take. The limitations that are most important for 
healthcare professionals to know about the intended use of tests that 
fall under this device type are, under Sec.  866.5950(b)(1)(ii), 
required to be provided in the Sec.  809.10 labeling and any test 
report generated. These limitations include that the test is intended 
to provide users with their genetic information to inform lifestyle 
decisions and conversations with their doctor or other healthcare 
professional and that any diagnostic or treatment decisions should be 
based on testing and/or other information that a healthcare 
professional determines to be appropriate for a patient.

E. Rigorous Validation Requirements

    FDA believes the analytical validation requirements are 
sufficiently detailed in the special controls under Sec.  
866.5950(b)(3)(iii)(J) that test providers will have no difficulty in 
appropriately following these requirements. A high accuracy requirement 
is necessary for tests that are provided under this regulation and 
accuracy point estimates for all variants is required to be 99 percent 
or higher under Sec.  866.5950(b)(3)(iii)(J)(1)(vii) or else they 
cannot be claimed or reported. Once FDA has reviewed one test that 
demonstrates this level of accuracy, then the test provider has 
demonstrated an ability to meet the accuracy requirements for 
additional similar tests offered.

F. Four Important Limitations on the Scope of the Classification 
Regulation

    FDA agrees that there are four important express limitations to the 
types of tests that can be offered under this classification regulation 
even when these special controls are met. Tests cannot be offered under 
this classification regulation that are indicated for prenatal testing; 
predisposition for cancer where the result of the test may lead to 
prophylactic screening, confirmatory procedures, or treatments that may 
incur morbidity or mortality to the patient; assessing the presence of 
genetic variants that impact the metabolism, exposure, response, risk 
of adverse events, dosing, or mechanisms of prescription or OTC 
medications; or assessing the presence of deterministic autosomal 
dominant variants.

G. False or Misleading Claims

    It is a prohibited act for devices to have labeling that is false 
or misleading in any particular manner, and thus FDA would deem such 
device to be misbranded under section 502(a) of the FD&C Act (21 U.S.C. 
352(a)). This prohibition would include prohibiting the manufacturer of 
a genetic health risk assessment test device from falsely or 
misleadingly representing a test as having been part of an original FDA 
cleared device when it was added subsequently to FDA clearance. This 
prohibition would also include falsely or misleadingly representing the 
analytical or clinical validity of one of its tests. In addition, under 
section 502(c) of the FD&C Act, it is a prohibited act and thus FDA 
would deem a device to be misbranded if any information required on the 
labeling of a device by FDA by or under the FD&C Act is not placed 
prominently thereon with such conspicuousness and in such terms, as to 
render it likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use. Thus, a genetic health 
risk assessment test device for which a manufacturer later modified the 
formerly compliant labeling to make the labeling such that the labeling 
was not likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use would be a misbranded 
device.

H. Conclusion

    In summary, all tests that are marketed under this classification 
regulation must meet the general controls and the special controls that 
are specified in the regulation. Ability of a manufacturer to meet 
these special controls is demonstrated during the one-time review. Even 
after the one-time review, the general controls and special controls 
must continue to be met, including for all tests added or modified 
after the one-time review of a manufacturer's device.

IV. Limitations on Exemptions

    FDA has determined that 510(k) 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 exemption from 510(k) 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. A manufacturer of a listed 
device is still required to submit a 510(k) to FDA before introducing a 
device or delivering it for introduction into commercial distribution 
when the device meets any of the conditions described in Sec. Sec.  
862.9 to 892.9 (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 510(k) 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 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 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 
has determined 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 has determined 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 as well as to ensure the 
devices perform to acceptable standards.
    Exemption from the requirement of 510(k) does not exempt a device 
from other applicable regulatory controls under the FD&C Act, including 
the applicable general and special controls. This exemption from 
510(k), subject to the limitations described above, is immediately in 
effect for the device types identified in table 1. This exemption will 
decrease regulatory burdens on the medical device industry and will 
eliminate private costs and

[[Page 25914]]

expenditures required to comply with Federal regulations.

V. List of Class II Devices

    FDA is identifying the following list of class II devices that will 
no longer require premarket notification under section 510(k) of the 
FD&C Act, subject to the general limitations to the exemptions found in 
Sec. Sec.  862.9 to 892.9 and any partial exemption limitations 
identified in table 1:

                                            Table 1--Class II Devices
----------------------------------------------------------------------------------------------------------------
                                                                                          Partial exemption
           21 CFR section                   Device type            Product code       limitation (if applicable)
----------------------------------------------------------------------------------------------------------------
862.1840............................  Total 25-hydroxyvitamin  PSL                   ...........................
                                       D Mass Spectrometry
                                       Test System.
866.5950............................  Genetic Health Risk      PTA                   Exemption is limited to a
                                       Assessment System.                             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............................  Endoscope Disinfectant   PUP                   ...........................
                                       Basin.
880.6710............................  Purifier, Water,         KMG                   ...........................
                                       Ultraviolet, Medical.
884.5960............................  Vibrator for             KXQ                   ...........................
                                       Therapeutic Use,
                                       Genital.
----------------------------------------------------------------------------------------------------------------

    FDA is revising the name of product code PUP to further clarify the 
device type that this product code is intended to represent. The device 
type was previously ``Endoscope Maintenance System.'' To more 
accurately reflect the devices which fall within this device type 
(product code PUP), the device type has been renamed ``Endoscope 
Disinfectant Basin.'' Specifically, these devices are described as 
``Wall-mounted tube(s) for holding disinfectant solution and endoscope 
insertion tubes and accessories.'' This description has not changed 
since publication of the November 2017 notice.

VI. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in other FDA regulations and guidance. These 
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. 3501-3520). The collections of information in part 807, 
subpart E, regarding premarket notification submissions, have been 
approved under OMB control number 0910-0120; and the collections of 
information in 21 CFR parts 801 and 809, regarding labeling, have been 
approved under OMB control number 0910-0485.

List of Subjects

21 CFR Part 862

    Medical devices.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Parts 876, 880, and 884

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
862, 866, 876, 880, and 884 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. In Sec.  862.1840, revise paragraph (b) introductory text to read as 
follows:


Sec.  862.1840  Total 25-hydroxyvitamin D mass spectrometry test 
system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in part 807, subpart 
E, of this chapter subject to the limitations in Sec.  862.9. The 
device must comply with the following special controls:
* * * * *

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
3. The authority citation for part 866 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
4. In Sec.  866.5950, revise paragraph (b) introductory text to read as 
follows:


Sec.  866.5950  Genetic health risk assessment system.

* * * * *
    (b) Classification. Class II (special controls). The genetic health 
risk assessment system device, when it has previously 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''), is exempt from the premarket 
notification procedures in part 807, subpart E, of this chapter subject 
to the limitations in Sec.  866.9. The device must comply with the 
following special controls:
* * * * *

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
5. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
6. In Sec.  876.1500, revise paragraph (b)(1) to read as follows:


Sec.  876.1500  Endoscope and accessories.

* * * * *
    (b) * * *
    (1) Class II (performance standards). The device, when intended as 
an endoscope disinfectant basin, which consists solely of a container 
that holds disinfectant and endoscopes and accessories, is exempt from 
the premarket notification procedures in part 807, subpart E, of this 
chapter subject to the limitations in Sec.  876.9.
* * * * *

[[Page 25915]]

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
7. The authority citation for part 880 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
8. In Sec.  880.6710, revise paragraph (b) to read as follows:


Sec.  880.6710  Medical ultraviolet water purifier.

* * * * *
    (b) Classification. Class II (performance standards). The device is 
exempt from the premarket notification procedures in part 807, subpart 
E, of this chapter subject to the limitations in Sec.  880.9.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
9. The authority citation for part 884 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
10 In Sec.  884.5960, revise paragraph (b) to read as follows:


Sec.  884.5960  Genital vibrator for therapeutic use.

* * * * *
    (b) Classification. Class II (performance standards). The device is 
exempt from the premarket notification procedures in part 807, subpart 
E, of this chapter subject to the limitations in Sec.  884.9.

    Dated: May 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11879 Filed 6-1-18; 8:45 am]
BILLING CODE 4164-01-P