Document ID: FDA-2018-N-3595-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use
Posted Date: 2018-10-19T04:00Z

[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52970-52972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-3595]

Medical Devices; General and Plastic Surgery Devices; 
Classification of the Hemostatic Device for Intraluminal 
Gastrointestinal Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the hemostatic device for intraluminal gastrointestinal use 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 hemostatic device for intraluminal gastrointestinal 
use'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, in part by reducing regulatory burdens.

DATES: This order is effective October 19, 2018. The classification was 
applicable on May 7, 2018.

FOR FURTHER INFORMATION CONTACT: Maegen Colehour, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993-0002, 301-
796-6436, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the hemostatic device for 
intraluminal gastrointestinal use as class II (special controls), which 
we have determined will provide a reasonable assurance of safety and 
effectiveness. 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 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 (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 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. 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.
    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 21 U.S.C. 360c(f)(2)(B)(i)). 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 21 U.S.C. 360c(i), defining ``substantial equivalence''). 
Instead, sponsors can use the less-burdensome 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    On March 9, 2017, Wilson-Cook Medical, Inc. submitted a request for 
De Novo classification of the Hemospray[supreg] Endoscopic Hemostat. 
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 May 7, 2018, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4456. We have named 
the generic type of device hemostatic device for intraluminal 
gastrointestinal use, and it is identified as a prescription device 
that is endoscopically applied to the upper and/or lower 
gastrointestinal tract and is intended to produce hemostasis via 
absorption of fluid or by other means.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures

[[Page 52971]]

required to mitigate these risks in table 1.

 Table 1--Hemostatic Device for Intraluminal Gastrointestinal Use Risks
                         and Mitigation Measures
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           Identified risks                   Mitigation measures
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Bleeding:
     Inability to achieve      In vivo performance testing, Non-
     hemostasis                         clinical performance testing,
     Recurrence of bleeding..   and Labeling.
Infection............................  Sterilization validation, Shelf
                                        life testing, and Labeling.
Adverse tissue reaction..............  In vivo performance testing, Non-
                                        clinical performance testing,
                                        Biocompatibility evaluation, and
                                        Labeling.
Obstruction of gastrointestinal (GI)   In vivo performance testing and
 tract.                                 Labeling.
GI distension or perforation.........  In vivo performance testing and
                                        Labeling.
Vascular obstruction:
     Ischemia                  In vivo performance testing, Non-
     Emboli formation........   clinical performance testing,
                                        and Labeling.
Tissue trauma........................  In vivo performance testing, Non-
                                        clinical performance testing,
                                        and Labeling.
Improper device use..................  In vivo performance testing and
                                        Labeling.
------------------------------------------------------------------------

    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. We encourage sponsors to consult with us if they wish to 
use a non-animal testing method they believe is suitable, adequate, 
validated, and feasible. We will consider if such an alternative method 
could be assessed for equivalency to an animal test method. This device 
is subject to premarket notification requirements under section 510(k) 
of the FD&C Act.
    At the time of classification, hemostatic devices for intraluminal 
gastrointestinal use are for prescription use only. Prescription 
devices are exempt from the requirement for adequate directions for use 
for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 
352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 
801.109 are met (referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have 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. 3501-3520). The collections 
of information in the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' 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 21 CFR part 820, regarding 
quality system regulations, have been approved under OMB control number 
0910-0073; 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 part 801, regarding labeling, have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 878

    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 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Add Sec.  878.4456 to subpart E to read as follows:

Sec.  878.4456  Hemostatic device for intraluminal gastrointestinal 
use.

    (a) Identification. A hemostatic device for intraluminal 
gastrointestinal use is a prescription device that is endoscopically 
applied to the upper and/or lower gastrointestinal tract and is 
intended to produce hemostasis via absorption of fluid or by other 
physical means.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Performance data must support the sterility and pyrogenicity of 
the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (4) In vivo performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. The testing 
must evaluate the following:
    (i) The ability to deliver the hemostatic material to the bleeding 
site;
    (ii) The ability to achieve hemostasis in a clinically relevant 
model of gastrointestinal bleeding; and
    (iii) Safety endpoints, including thromboembolic events, local and 
systemic toxicity, tissue trauma, gastrointestinal tract obstruction, 
and bowel distension and perforation.
    (5) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Materials characterization of all components must demonstrate 
the device meets established specifications, which must include 
compositional identity and purity, characterization of

[[Page 52972]]

impurities, physical characteristics, and reactivity with fluids.
    (ii) Performance testing must demonstrate the mechanical integrity 
and functionality of the system used to deliver the device and 
demonstrate the device meets established specifications, including 
output pressure for propellant-based systems.
    (6) Labeling must include:
    (i) Information identifying and explaining how to use the device 
and its components; and
    (ii) A shelf life.

    Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22784 Filed 10-18-18; 8:45 am]
BILLING CODE 4164-01-P