83 FR 6793 - Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 32 (February 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 32 (February 15, 2018)
| Page Range | 6793-6795 | |
| FR Document | 2018-03135 |
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)] [Rules and Regulations] [Pages 6793-6795] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Rules and Regulations 6793
searching for and locating Docket No. FAA– I. Background then requests a classification under
2018–0109. section 513(f)(2).
(2) For more information about this AD, Upon request, FDA has classified the Under the second procedure, rather
contact Sanjay Ralhan, Aerospace Engineer, non-absorbable, hemostatic gauze for than first submitting a 510(k) and then
International Section, Transport Standards temporary internal use as class II a request for classification, if the person
Branch, FAA, 1601 Lind Avenue SW, (special controls), which we have
Renton, WA 98057–3356; telephone: 425–
determines that there is no legally
determined will provide a reasonable marketed device upon which to base a
227–1405; fax: 425–227–1149. assurance of safety and effectiveness. In determination of substantial
(k) Material Incorporated by Reference addition, we believe this action will equivalence, that person requests a
None. enhance patients’ access to beneficial classification under section 513(f)(2) of
innovation, in part by reducing the FD&C Act.
Issued in Renton, Washington, on February
12, 2018.
regulatory burdens by placing the Under either procedure for De Novo
device into a lower device class than the classification, FDA shall classify the
Michael Kaszycki,
automatic class III assignment. device by written order within 120 days.
Acting Director, System Oversight Division,
Aircraft Certification Service. The automatic assignment of class III The classification will be according to
occurs by operation of law and without the criteria under section 513(a)(1) of
[FR Doc. 2018–03185 Filed 2–14–18; 8:45 am]
any action by FDA, regardless of the the FD&C Act. Although the device was
BILLING CODE 4910–13–P
level of risk posed by the new device. automatically placed within class III,
Any device that was not in commercial the De Novo classification is considered
distribution before May 28, 1976, is to be the initial classification of the
automatically classified as, and remains device.
DEPARTMENT OF HEALTH AND We believe this De Novo classification
within, class III and requires premarket
HUMAN SERVICES will enhance patients’ access to
approval unless and until FDA takes an
Food and Drug Administration action to classify or reclassify the device beneficial innovation, in part by
(see 21 U.S.C. 360c(f)(1)). We refer to reducing regulatory burdens. When FDA
21 CFR Part 878 these devices as ‘‘postamendments classifies a device into class I or II via
devices’’ because they were not in the De Novo process, the device can
commercial distribution prior to the serve as a predicate for future devices of
[Docket No. FDA–2018–N–0370] that type, including for 510(k)s (see 21
date of enactment of the Medical Device
Amendments of 1976, which amended U.S.C. 360c(f)(2)(B)(i)). As a result, other
Medical Devices; General and Plastic
the Federal Food, Drug, and Cosmetic device sponsors do not have to submit
Surgery Devices; Classification of the
Act (FD&C Act). a De Novo request or premarket
Non-Absorbable, Hemostatic Gauze for
FDA may take a variety of actions in approval application in order to market
Temporary Internal Use
appropriate circumstances to classify or a substantially equivalent device (see 21
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We U.S.C. 360c(i), defining ‘‘substantial
HHS. may issue an order finding a new device equivalence’’). Instead, sponsors can use
ACTION: Final order. to be substantially equivalent under the less-burdensome 510(k) process,
section 513(i) of the FD&C Act to a when necessary, to market their device.
SUMMARY: The Food and Drug predicate device that does not require II. De Novo Classification
Administration (FDA or we) is premarket approval (see 21 U.S.C.
classifying the non-absorbable, On March 16, 2016, Z-Medica, LLC,
360c(i)). We determine whether a new
hemostatic gauze for temporary internal submitted a request for De Novo
device is substantially equivalent to a
use into class II (special controls). The classification of the D2 Dressing. FDA
predicate by means of the procedures
special controls that apply to the device reviewed the request in order to classify
for premarket notification under section
type are identified in this order and will the device under the criteria for
510(k) of the FD&C Act and part 807 (21
be part of the codified language for the classification set forth in section
U.S.C. 360(k) and 21 CFR part 807,
non-absorbable, hemostatic gauze for 513(a)(1) of the FD&C Act.
respectively). We classify devices into class II if
temporary internal use’s classification. FDA may also classify a device
We are taking this action because we general controls by themselves are
through ‘‘De Novo’’ classification, a insufficient to provide reasonable
have determined that classifying the common name for the process
device into class II (special controls) assurance of safety and effectiveness,
authorized under section 513(f)(2) of the but there is sufficient information to
will provide a reasonable assurance of FD&C Act. Section 207 of the Food and
safety and effectiveness of the device. establish special controls that, in
Drug Administration Modernization Act combination with the general controls,
We believe this action will also enhance of 1997 established the first procedure
patients’ access to beneficial innovative provide reasonable assurance of the
for De Novo classification (Pub. L. 105– safety and effectiveness of the device for
devices, in part by reducing regulatory 115). Section 607 of the Food and Drug
burdens. its intended use (see 21 U.S.C.
Administration Safety and Innovation 360c(a)(1)(B)). After review of the
DATES: This order is effective February Act modified the De Novo application information submitted in the request,
15, 2018. The classification was process by adding a second procedure we determined that the device can be
applicable on June 30, 2017. (Pub. L. 112–144). A device sponsor classified into class II with the
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De establishment of special controls. FDA
sradovich on DSK3GMQ082PROD with RULES
Peter Hudson, Center for Devices and Novo classification. has determined that these special
Radiological Health, Food and Drug Under the first procedure, the person controls, in addition to the general
Administration, 10903 New Hampshire submits a 510(k) for a device that has controls, will provide reasonable
Ave., Bldg. 66, Rm. G434, Silver Spring, not previously been classified. After assurance of the safety and effectiveness
MD 20993–0002, 301–796–6440, receiving an order from FDA classifying of the device.
peter.hudson@fda.hhs.gov. the device into class III under section Therefore, on June 30, 2017, FDA
SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person issued an order to the requester
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(6) Labeling must include the The Wantagh State Parkway Bridge, DATES: This deviation is effective from
following: across Sloop Channel, mile 15.4, has a 6:30 a.m. on February 19, 2018 to 11:59
(i) Instructions for use, including an vertical clearance of 16 feet at mean p.m. on March 23, 2018.
instruction to remove all visible device high water and 19.5 feet at mean low
ADDRESSES: The docket for this
components by irrigation; water in the closed position. The
deviation, USCG–2018–0080 is available
(ii) The maximum amount of time the existing drawbridge operating regulation
at http://www.regulations.gov. Type the
device may be left within the body; is listed at 33 CFR 117.5.
The temporary deviation will allow docket number in the ‘‘SEARCH’’ box
(iii) A shelf life; and click ‘‘SEARCH’’. Click on Open
(iv) A contraindication for the Wantagh Parkway Bridge to remain
closed from 9 p.m. to 11:59 p.m. on July Docket Folder on the line associated
intravascular use of the device; and with this deviation.
(v) A warning regarding the potential 4, 2018. Sloop Channel is transited by
for adhesion formation. seasonal recreational vessels and FOR FURTHER INFORMATION CONTACT: If
Dated: February 9, 2018.
commercial fishing vessels. you have questions on this temporary
Coordination with Coast Guard Sector deviation, call or email Mr. Jeffrey Stieb,
Leslie Kux,
Long Island Sound has indicated no First Coast Guard District Bridge
Associate Commissioner for Policy. mariner objections to the proposed Branch, Coast Guard; telephone 617–
[FR Doc. 2018–03135 Filed 2–14–18; 8:45 am] short-term closure of the draw. 223–8364, email Jeffrey.D.Stieb@
BILLING CODE 4164–01–P Vessels that can pass under the bridge uscg.mil.
without an opening may do so at all
times. The bridge will be able to open SUPPLEMENTARY INFORMATION: The owner
DEPARTMENT OF HOMELAND for emergencies. There is no alternate of the bridge, the New Hampshire
SECURITY route for vessels to pass. Department of Transportation (NH
The Coast Guard will also inform the DOT), requested a temporary deviation
Coast Guard users of the waterways through our to replace the failed couplings to the
Local and Broadcast Notices to Mariners operating machinery of the bridge. The
33 CFR Part 117 of the change in operating schedule for SR1A Bridge across the Hampton River,
the bridge so that vessel operators can mile 0.0, at Hampton, New Hampshire,
[Docket No. USCG–2018–0051]
arrange their transits to minimize any has a vertical clearance in the closed
Drawbridge Operation Regulation; impact caused by the temporary position of 18 feet at mean high water
Sloop Channel, Hempstead, NY deviation. and 26.5 feet at mean low water. The
In accordance with 33 CFR 117.35(e), existing bridge operating regulations are
AGENCY: Coast Guard, DHS. the drawbridge must return to its regular found at 33 CFR 117.697.
ACTION:Notice of deviation from operating schedule immediately at the This temporary deviation allows the
drawbridge regulation. end of the effective period of this bridge to remain in the closed to
temporary deviation. This deviation navigation position from 6:30 a.m. on
SUMMARY: The Coast Guard has issued a from the operating regulations is February 19, 2018, through 11:59 p.m.
temporary deviation from the operating authorized under 33 CFR 117.35. on March 23, 2018. The deviation will
schedule that governs the Wantagh State have negligible effect on vessel
Dated: February 1, 2018.
Parkway Bridge across Sloop Channel, navigation. The waterway is transited
Christopher J. Bisignano,
mile 15.4, at Hempstead, New York. primarily by seasonal recreational
This deviation is necessary in order to Supervisory Bridge Management Specialist,
First Coast Guard District. vessels and small commercial fishing
facilitate an annual fireworks display vessels. In 2016 and in 2017 there were
and allows the bridge to remain in the [FR Doc. 2018–03175 Filed 2–14–18; 8:45 am]
BILLING CODE 9110–04–P
only three openings in the month of
closed position for three hours. March.
DATES: This deviation is effective from NH DOT has met and maintained
9 p.m. to 11:59 p.m. on July 4, 2018. DEPARTMENT OF HOMELAND frequent communication with waterway
ADDRESSES: The docket for this SECURITY users, the harbormaster and town
deviation, USCG–2018–0051, is officials through direct contact and
available at http://www.regulations.gov. Coast Guard public meetings. No objections to the
Type the docket number in the proposed closure were received. Vessels
‘‘SEARCH’’ box and click ‘‘SEARCH’’. 33 CFR Part 117 that can pass through the bridge in the
Click on Open Docket Folder on the line [Docket No. USCG–2018–0080] closed position may do so. The bridge
associated with this deviation. will not be able to open for emergencies
FOR FURTHER INFORMATION CONTACT: If Drawbridge Operation Regulation; and there is no immediate alternate
you have questions on this temporary Hampton River, Hampton, NH route for vessels unable to pass through
deviation, call or email Judy K. Leung- the bridge in the closed position. The
AGENCY: Coast Guard, DHS.
Yee, Bridge Management Specialist, Coast Guard will inform waterway users
First District Bridge Branch, U.S. Coast ACTION:Notice of deviation from of the closure through Local and
Guard; telephone 212–514–4336, email drawbridge regulation. Broadcast Notices to Mariners in order
Judy.K.Leung-Yee@uscg.mil. SUMMARY: The Coast Guard has issued a to minimize any impact caused by the
SUPPLEMENTARY INFORMATION: The New temporary deviation from the operating temporary deviation.
sradovich on DSK3GMQ082PROD with RULES
York State Office of Parks, Recreation, schedule that governs the SR1A Bridge In accordance with 33 CFR 117.35(e),
and Historic Preservation requested and across the Hampton River, mile 0.0, at the drawbridge must return to its regular
the bridge owner, the New York State Hampton, NH. The deviation is operating schedule immediately at the
Department of Transportation, necessary to allow the replacement of end of the effective period of this
concurred with this temporary deviation couplers on the bridge. This deviation temporary deviation. This deviation
from the normal operating schedule to allows the bridge to be closed to from the operating regulations is
facilitate a public fireworks display. navigation. authorized under 33 CFR 117.35.
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Document Created: 2018-02-15 00:20:57
Document Modified: 2018-02-15 00:20:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective February 15, 2018. The classification was applicable on June 30, 2017. | |
| 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] | |
| FR Citation | 83 FR 6793 |
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