Document ID: FDA-2019-N-2686-0002
Agency: fda
Document Type: Rule
Title: Medical Devices; Exemptions From Premarket Notification: Class II Devices
Posted Date: 2020-07-22T04:00Z

[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Rules and Regulations]
[Pages 44186-44188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15256]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 884, 888, and 890

[Docket No. FDA-2019-N-2686]

Medical Devices; Exemptions From Premarket Notification: Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
publishing an order setting forth the Agency's final determination 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 list of class II devices. The 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 list of class II 
devices to reflect this final determination. FDA is publishing this 
order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C 
Act).

DATES: This order is effective July 22, 2020.

FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1528, Silver Spring, MD 20993, 301-796-6424, 
Jismi.johnson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its 
implementing regulations in part 807, subpart E (21 CFR part 807, 
subpart E), persons 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 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 (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) of the 
FD&C Act provides that, 1 calendar day after the date of publication of 
the final list under section 510(m)(1)(B) of the FD&C Act,\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 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.
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    \1\ FDA published the final list under section 510(m)(1)(B) of 
the FD&C Act in the Federal Register of July 11, 2017 (82 FR 31976).
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    In the Federal Register of October 25, 2019 (84 FR 57445), in 
accordance with the amendments to section 510(m)(2) of the FD&C Act, on 
its own initiative, FDA issued a notice of intent to exempt the 
identified class II devices from premarket notification requirements 
under section 510(k) of the FD&C Act, subject to certain limitations. 
Having received no comments to the docket following a 60-day comment 
period, FDA is issuing this order to set forth our final determination 
to exempt the class II devices that were the subject of the notice. 
Through this action, FDA is now amending the codified language for each 
identified classification regulation to reflect our final 
determinations for these class II exemptions.\2\
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    \2\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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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 we issued on February 19, 1998, entitled ``Procedures 
for Class II Device Exemptions From Premarket Notification, Guidance 
for Industry and

[[Page 44187]]

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.

III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to 
provide a reasonable assurance of 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 premarket notification for the 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. 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 884.9, 888.9, and 890.9.

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 an 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 optical position/movement recording system 
but limits the exemption to such devices that are for prescription use 
only. FDA believes that premarket review (e.g., premarket notification) 
of an optical position/movement recording system for over-the-counter 
(OTC) use is necessary to ensure that the exercises and activities led 
by the system are appropriate for a user's rehabilitation and to assess 
the measurement accuracy of the system. Additionally, a therapeutic 
massager to internally massage trigger points in the pelvic floor 
musculature would exceed the exemption limitation and would require 
510(k) review if it is indicated for OTC use, lacks a quantitative 
feedback mechanism, or lacks a disposable covering.

IV. List of Class II Devices

    In this final order, 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 21 CFR 884.9, 888.9, and 890.9 and any partial 
exemption limitations identified in Table 1.
    FDA assigned new product codes to the device types that are exempt 
subject to the partial limitations 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 now have distinct product codes).

                                            Table 1--Class II Devices
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                                                                           Non-exempt        Partial exemption
         21 CFR section             Device type      Exempt  product      product code        limitation  (if
                                                           code           (non-exempt)          applicable)
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884.6120.......................  Accessory,         QKH..............  MQG..............  Exemption is limited
                                  Assisted                                                 to assisted
                                  Reproduction.                                            reproduction laminar
                                                                                           flow workstations.
884.6180.......................  Media,             QKI..............  MQL..............  Exemption is limited
                                  Reproductive.                                            to phosphate-buffered
                                                                                           saline used for
                                                                                           washing, and short-
                                                                                           term handling and
                                                                                           manipulation of
                                                                                           gametes and embryos;
                                                                                           culture oil used as
                                                                                           an overlay for
                                                                                           culture media
                                                                                           containing gametes
                                                                                           and embryos; and
                                                                                           water for assisted
                                                                                           reproduction
                                                                                           applications.
888.4505.......................  Instruments        Not Applicable...  QBO..............  Not Applicable.
                                  Designed for
                                  Press-Fit
                                  Osteochondral
                                  implants.
890.5360 *.....................  Interactive        QKC..............  LXJ..............  Exemption is limited
                                  Rehabilitation                                           to prescription (Rx)
                                  Exercise Devices.                                        use only.
890.5670.......................  Massager,          QKD..............  OSD..............  Exemption is limited
                                  Therapeutic, to                                          to prescription (Rx)
                                  Internally                                               use only devices
                                  Massage Trigger                                          which incorporate a
                                  Points in the                                            quantitative feedback
                                  Pelvic Floor                                             mechanism and a
                                  Musculature.                                             disposable covering.
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* FDA is revising the name of the device type under product code LXJ from ``System, Optical Position/Movement
  Recording'' to ``Interactive Rehabilitation Exercise Devices.''

    FDA is also revising the name of product code LXJ to further 
clarify the device type that this product code is intended to 
represent, identified with an asterisk in table 1. The device type was 
previously ``System, Optical Position/Movement Recording.'' This 
product code also includes types of rehabilitation devices other than 
optical position/movement recording systems; therefore, to more 
accurately reflect the devices which fall within this device type 
(product code LXJ), the device type has been renamed ``Interactive 
Rehabilitation Exercise Devices.'' The new product code, QKC, which 
represents the class II exempt counterpart of LXJ and reflects the 
partial exemption limited to prescription use, also reflects this name 
change.

V. 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,

[[Page 44188]]

neither an environmental assessment nor an environmental impact 
statement is required.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this final order contains no new collection of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521) is not required. This final order refers to previously approved 
FDA collections of information. These collections of information are 
subject to review by OMB under the PRA. The collections of information 
in in 21 CFR part 807, subpart E, regarding premarket notification 
submissions, have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR parts 801 and 809, regarding 
labeling, have been approved under OMB control number 0910-0485; and 
the collections of information in part 820, regarding quality system 
regulation, have been approved under OMB control number 0910-0073.

List of Subjects in 21 CFR Parts 884, 888, and 890

    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 
884, 888, and 890 are amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

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

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

0
2. In Sec.  884.6120, revise paragraph (b) to read as follows:

Sec.  884.6120  Assisted reproduction accessories.

* * * * *
    (b) Classification. Class II (special controls) (design 
specifications, labeling requirements, and clinical testing). The 
device, when it is a simple embryo incubator with only temperature, 
gas, and humidity control; a syringe pump; a collection tube warmer; a 
dish/plate/microscope stage warmer; a controlled-rate cryopreservation 
freezer; or an assisted reproduction laminar flow workstation is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  884.9.

0
3. In Sec.  884.6180, revise paragraph (b) to read as follows:

Sec.  884.6180   Reproductive media and supplements.

* * * * *
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, biocompatibility testing, and 
clinical testing). The device, when it is phosphate-buffered saline 
used for washing, and short-term handling and manipulation of gametes 
and embryos; culture oil used as an overlay for culture media 
containing gametes and embryos; and water for assisted reproduction 
applications, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  884.9.

PART 888--ORTHOPEDIC DEVICES

0
4. The authority citation for part 888 continues to read as follows:

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

0
5. Amend Sec.  888.4505 by revising paragraph (b) introductory text to 
read as follows:

Sec.  888.4505  Orthopedic surgical instrumentation designed for 
osteochondral implants with press-fit fixation.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  888.9. The 
special controls for this device are:
* * * * *

PART 890--PHYSICAL MEDICINE DEVICES

0
6. The authority citation for part 890 continues to read as follows:

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

0
7. In Sec.  890.5360, revise paragraph (b) to read as follows:

Sec.  890.5360   Measuring exercise equipment.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a measuring exerciser or an interactive rehabilitation exercise 
device for prescription use only, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  890.9.

0
8. Amend Sec.  890.5670 by revising paragraph (b) introductory text to 
read as follows:

Sec.  890.5670  Internal therapeutic massager.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is for prescription use only with a quantitative feedback mechanism 
and a disposable covering, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  890.9. The special controls for this device are:
* * * * *

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15256 Filed 7-21-20; 8:45 am]
BILLING CODE 4164-01-P