Rule2026-20075
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
Primary source
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Published
September 30, 2026
Effective
September 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature 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 classification of the flushing and storage solution for vascular autografts at room temperature. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 91 Issue 188 (Wednesday, September 30, 2026)</title>
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[Federal Register Volume 91, Number 188 (Wednesday, September 30, 2026)]
[Rules and Regulations]
[Pages 61703-61705]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2026-N-10991]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Flushing and Storage Solution for Vascular Autografts at Room
Temperature
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
flushing and storage solution for vascular autografts at room
temperature 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 classification of the flushing and storage
solution for vascular autografts at room temperature. We are taking
this action because we have determined that classifying the device into
class II will provide a reasonable assurance of the safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.
DATES: This order is effective September 30, 2026. The classification
was applicable on October 4, 2023.
FOR FURTHER INFORMATION CONTACT: Jordana Gilbert-Honick, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2524, Silver Spring, MD 20993-0002,
301-796-6873, <a href="/cdn-cgi/l/email-protection#a0eacfd2c4c1cec18ee7c9ccc2c5d2d48de8cfcec9c3cbe0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="3872574a5c595659167f51545a5d4a4c15705756515b53785e5c591650504b165f574e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the flushing
and storage solution for vascular autografts at room temperature into
class II (special controls), which we have determined will provide a
reasonable assurance of the safety and effectiveness of the device. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
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 into, and remains
within, class III and requires premarket approval unless and until
[[Page 61704]]
FDA takes an action to classify or reclassify the device (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 (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
classification 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 premarket
notification (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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On January 3, 2023, FDA received Marizyme, Inc.'s request for De
Novo classification of the DuraGraft Vascular Conduit Solution. 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 the safety and
effectiveness of the device, 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 section 513(a)(1)(B) of the
FD&C Act). 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 October 4, 2023, 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
876.4100.\1\ We have named the generic type of device ``flushing and
storage solution for vascular autografts at room temperature,'' and it
is identified as a device that is used for flushing or short-term
storage of vascular grafts. This generic type of device is intended to
maintain cell viability and structural integrity of vascular grafts
during short-term storage at room temperature during the surgical
procedure.
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\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.
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FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Flushing and
Storage Solutions for Vascular Autografts at Room Temperature
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
Damage to vascular grafts leading to Clinical performance data; Non-
major adverse cardiac events or clinical performance testing;
vascular injury.. Shelf life testing; and
Labeling.
Particulate matter contamination Clinical performance data; Non-
leading to vascular occlusion, clinical performance testing;
coronary artery embolization and Shelf life testing; and
occlusion, phlebitis, infarction, and Labeling.
death.
Infection.............................. Sterilization validation.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness of the device. 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
[[Page 61705]]
named in this final order. The necessary special controls appear in the
regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for flushing and storage
solutions for vascular autografts at room temperature. This device is
therefore 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 normally 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 management 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 876
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
876 is amended as follows:
PART 876--GASTROENTEROLOGY/UROLOGY DEVICES
0
1. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 876.4100 to subpart E to read as follows:
Sec. 876.4100 Flushing and storage solution for vascular autografts
at room temperature.
(a) Identification. A flushing and storage solution for vascular
autografts at room temperature is a device that is used for flushing or
short-term storage of vascular grafts. This generic type of device is
intended to maintain cell viability and structural integrity of
vascular grafts during short-term storage at room temperature during
the surgical procedure.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical data must evaluate adverse events associated with
clinical use of the device. Devices indicated for vascular grafts for
coronary artery bypass graft surgeries must include an evaluation of
the incidence of major adverse cardiac events, vein graft occlusion,
and mortality.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Maintenance of cell viability and structural integrity of
vascular conduits during storage at the labeled temperature and storage
duration; and
(ii) Evaluation of visible and non-visible particulates in the
final mixed solution.
(3) Shelf life testing must demonstrate the stability of the
device's chemical components over the identified shelf life.
(4) The device must be demonstrated to be biocompatible.
(5) Performance data must demonstrate the sterility of the device.
(6) Labeling must include:
(i) The maximum storage duration for vascular autografts in the
solution;
(ii) A description of all additives or supplements that are added
at the point of care;
(iii) The need for visual inspection of the solution for
particulate matter prior to use;
(iv) A statement regarding the duration of stability of the final
solution after preparation;
(v) A summary of the non-clinical performance testing that supports
use of the device as a flushing and storage solution for vascular
autografts; and
(vi) A summary of the clinical data that supports use of the device
as a flushing and storage solution for vascular autografts.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20075 Filed 9-29-26; 8:45 am]
BILLING CODE 4164-01-P
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