[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57445-57447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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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 (FD&C Act).

DATES: Submit either electronic or written comments on the notice by 
December 24, 2019.

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 December 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 24, 2019. 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-2019-N-2686 for ``Medical Devices; Exemptions from Premarket 
Notification: Class II Devices; Request for Comments.'' Received 
comments, those filed in a timely manner (see

[[Page 57446]]

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: Jismi Johnson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993, 301-796-6424, 
[email protected].

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. FDA is proposing to exempt a list of class II devices 
from premarket notification requirements, subject to certain 
limitations, upon its own initiative.

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. FDA proposes 
that a manufacturer of a listed device would

[[Page 57447]]

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 to 21 CFR 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 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 optical position/movement 
recording system but limits the exemption to such devices that are for 
prescription (Rx) use only. FDA believes that FDA 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

    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 Sec. Sec.  884.9 to 890.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
                                                             Partial
                                                            exemption
     21 CFR section         Device type    Product code   limitation (if
                                                           applicable)
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884.6120................  Accessory,       MQG           Exemption is
                           Assisted                       limited to
                           Reproduction.                  assisted
                                                          reproduction
                                                          laminar flow
                                                          workstations.
884.6180................  Media,           MQL           Exemption is
                           Reproductive.                  limited 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      QBO           ...............
                           Designed for
                           Press-Fit
                           Osteochondral
                           implants.
890.5360................  System, Optical  LXJ           Exemption is
                           Position/                      limited to
                           Movement                       prescription
                           Recording                      (Rx) use only.
                           (Interactive
                           Rehabilitation
                           Exercise
                           Devices).
890.5670................  Massager,        OSD           Exemption is
                           Therapeutic,                   limited to
                           to Internally                  prescription
                           Massage                        (Rx) use only
                           Trigger Points                 devices which
                           in the Pelvic                  incorporate a
                           Floor                          quantitative
                           Musculature.                   feedback
                                                          mechanism and
                                                          a disposable
                                                          covering.
------------------------------------------------------------------------

    FDA will assign new product codes to the device types that will be 
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).
    FDA is also revising the name of product code LXJ to further 
clarify the device type that this product code is intended to 
represent. 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.''

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 website address, as of the date this document publishes in 
the Federal Register, but websites 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/media/72685/download.

    Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23308 Filed 10-24-19; 8:45 am]
 BILLING CODE 4164-01-P