[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Rules and Regulations]
[Pages 6793-6795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03135]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-0370]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Non-Absorbable, Hemostatic Gauze for Temporary 
Internal Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the non-absorbable, hemostatic gauze for temporary internal 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 non-absorbable, hemostatic gauze for 
temporary internal 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 February 15, 2018. The classification 
was applicable on June 30, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Hudson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G434, Silver Spring, MD 20993-0002, 301-796-6440, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the non-absorbable, hemostatic 
gauze for temporary internal 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). 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 and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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 shall 
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 in order 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 16, 2016, Z-Medica, LLC, submitted a request for De Novo 
classification of the D2 Dressing. 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 June 30, 2017, FDA issued an order to the requester

[[Page 6794]]

classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4454. We have named 
the generic type of device non-absorbable, hemostatic gauze for 
temporary internal use, and it is identified as a prescription device 
intended to be placed temporarily for control of severely bleeding 
wounds such as surgical wounds and traumatic injuries. The gauze is 
coated or impregnated with a hemostatic material which may enhance 
hemostasis by physical means. The device is intended to be removed once 
the patient is stabilized.
    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--Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
                      Risks and Mitigation Measures
------------------------------------------------------------------------
          Identified risks                   Mitigation measures
------------------------------------------------------------------------
Infection..........................  Shelf life testing, Sterilization
                                      validation, and Labeling.
Bleeding...........................  Animal performance testing, and
                                      Technological specifications.
     Failure of hemostasis.
     Recurrence of bleeding
Vascular obstruction...............  Animal performance testing, and
                                      Labeling.
     Ischemia..............
     Emboli formation......
Adhesion formation.................  Animal performance testing, and
                                      Labeling.
Adverse tissue reaction............  Animal performance testing, and
                                      Biocompatibility evaluation.
Device retained in body leading to   Animal performance testing, Non-
 re-operation.                        clinical 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. This device is subject to premarket notification 
requirements under section 510(k).
    At the time of classification, non-absorbable, hemostatic gauze for 
temporary internal use is 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. 
502(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

    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. 3501-3520). 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 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.  878.4454 to subpart E to read as follows:


Sec.  878.4454  Non-absorbable, hemostatic gauze for temporary internal 
use.

    (a) Identification. A non-absorbable, hemostatic gauze for 
temporary internal use is a prescription device intended to be placed 
temporarily for control of severely bleeding wounds such as surgical 
wounds and traumatic injuries. The gauze is coated or impregnated with 
a hemostatic material which may enhance hemostasis by physical means. 
The device is intended to be removed once the patient is stabilized.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Animal performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Specifically 
testing must:
    (i) Demonstrate that the device is able to achieve hemostasis;
    (ii) Demonstrate that the device can be radiographically detected; 
and
    (iii) Assess pertinent safety endpoints including vascular 
obstruction and adhesion formation.
    (2) The device must be demonstrated to be biocompatible.
    (3) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
tests must be performed:
    (i) In vitro clot assessment;
    (ii) Particulate release testing;
    (iii) Physical characterization, including swelling percent and 
particulate size;
    (iv) Chemical characterization;
    (v) Radiopacity testing; and
    (vi) Mechanical integrity testing, including tensile strength and 
tear strength.
    (4) Performance data must demonstrate the sterility of the device.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.

[[Page 6795]]

    (6) Labeling must include the following:
    (i) Instructions for use, including an instruction to remove all 
visible device components by irrigation;
    (ii) The maximum amount of time the device may be left within the 
body;
    (iii) A shelf life;
    (iv) A contraindication for intravascular use of the device; and
    (v) A warning regarding the potential for adhesion formation.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03135 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P