Rule2024-19722
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 3, 2024
Effective
September 3, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external compression device for internal jugular vein compression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Rules and Regulations]
[Pages 71159-71160]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19722]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2024-N-3946]
Medical Devices; Physical Medicine Devices; Classification of the
External Compression Device for Internal Jugular Vein Compression
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the external compression device for internal jugular vein compression
into class II (special controls). The special controls that apply to
the device type are identified in this order and will be part of the
codified language for the external compression device for internal
jugular vein compression's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.
DATES: This order is effective September 3, 2024. The classification
was applicable on February 26, 2021.
FOR FURTHER INFORMATION CONTACT: Kenneth Morabito, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4240, Silver Spring, MD 20993-0002, 301-
796-3807, <a href="/cdn-cgi/l/email-protection#216a444f4f4455490f6c4e53404348554e614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="da91bfb4b4bfaeb2f497b5a8bbb8b3aeb59abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the external compression device
for internal jugular vein compression as class II (special controls),
which we have determined will provide a reasonable assurance of safety
and effectiveness.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo application
process by adding a second procedure. A device sponsor may utilize
either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
510(k) process, when necessary, to market their device.
II. De Novo Classification
On March 19, 2020, FDA received Q30 Sports Science's request for De
Novo classification of the Q-Collar. FDA reviewed the request in order
to classify the device under the criteria for classification set forth
in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on February 26, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
890.3050.\1\ We have named the generic type of device external
compression device for internal jugular vein compression, and it is
identified as a non-invasive device that is intended to increase
intracranial blood volume to reduce the occurrence of specific changes
in the brain following head
[[Page 71160]]
impacts sustained from the environment of use.
---------------------------------------------------------------------------
\1\ 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.
---------------------------------------------------------------------------
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--External Compression Device for Internal Jugular Vein
Compression Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Syncope due to excessive compression....... Non-clinical performance
testing.
Use error, interference with other Human factors testing, and
equipment, or ineffective treatment Labeling.
leading to impact-related trauma or injury.
Adverse tissue reaction.................... Biocompatibility
evaluation.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer 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. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 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 part
890 is amended as follows:
PART 890--PHYSICAL MEDICINE DEVICES
0
1. The authority citation for part 890 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 890.3050 to read as follows:
Sec. 890.3050 External compression device for internal jugular vein
compression.
(a) Identification. An external compression device for internal
jugular vein compression is a non-invasive device that is intended to
increase intracranial blood volume to reduce the occurrence of specific
changes in the brain following head impacts sustained from the
environment of use.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(2) Performance testing must demonstrate that the device performs
as intended under anticipated conditions of use for the duration of the
labeled use life.
(3) Human factors and usability testing must demonstrate that users
can correctly use the device, including the user's ability to correctly
determine device size and confirm the proper fit of the device. Users
must understand product limitations, warnings, and precautions,
including the warning that the device does not prevent head injury and
medical treatment should be sought following head injury.
(4) Labeling must include the following:
(i) A warning that the device does not replace, and should be worn
with, other protective sports equipment associated with specific sports
activities, such as helmets and shoulder pads;
(ii) A warning that the device should not be worn if it interferes
with other existing protective equipment;
(iii) A warning that users should avoid head and neck impacts to
the extent possible;
(iv) A warning that serious harm can result from persistent,
excessive pressure on the neck due to incorrect device size and fit;
and
(v) A warning that the device has not been demonstrated to prevent
long-term cognitive function deficits, and the ultimate impact on
clinical outcomes has not been evaluated.
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19722 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 3, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.