Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery, 61446-61448 [2017-28042]

Download as PDF 61446 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Rules and Regulations Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 16 and 511 are amended as follows: PART 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION 1. The authority citation for part 16 continues to read as follows: ■ Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. 2. In § 16.1, in paragraph (b)(2), revise the numerically sequenced entry for § 511.1(c)(1) to read as follows: ■ § 16.1 Scope. * * * * * (b) * * * (2) * * * (c)(1), relating to whether an investigator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. * * * * * PART 511—NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE 3. The authority citation for part 511 continues to read as follows: ■ Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371. 4. In § 511.1: a. Revise the section heading; b. Revise the last sentence in paragraph (c)(1); ■ c. Add paragraphs (c)(1)(i) and (ii); ■ d. Revise the last sentence in paragraph (c)(2); ■ e. Add paragraphs (c)(2)(i) and (ii); and ■ f. Revise paragraph (c)(6). The revisions and additions read as follows: sradovich on DSK3GMQ082PROD with RULES ■ ■ ■ Veterinary Medicine, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct: (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA; and (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. (2) * * * The notification also will explain that an investigator determined to be ineligible to receive test articles under this part will be ineligible to conduct: (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. * * * * * (6) An investigator who has been determined to be ineligible under paragraph (c)(2) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug, solely in compliance with the applicable provisions of this chapter. * * * * * Dated: December 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27973 Filed 12–27–17; 8:45 am] § 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act. BILLING CODE 4164–01–P * * * * * (c) * * * (1) * * * If an explanation is offered but not accepted by the Center for VerDate Sep<11>2014 16:07 Dec 27, 2017 Jkt 244001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA–2017–N–6842] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery’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 December 28, 2017. The classification was applicable on December 19, 2016. FOR FURTHER INFORMATION CONTACT: Mack Hall III, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3572, Silver Spring, MD 20993–0002, 301–796–5621, mack.hall@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Upon request, FDA has classified the pressure wedge for the reduction of cesarean delivery 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 E:\FR\FM\28DER1.SGM 28DER1 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Rules and Regulations 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 (21 U.S.C. 360c(f)(2)). 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 (21 U.S.C. 360c(a)(1)). Although the device was automatically 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 PMA 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 January 29, 2016, Stetrix, Inc., submitted a request for De Novo classification of the Hem-Avert® 61447 Perianal Stabilizer. 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 December 19, 2016, 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 884.5210. We have named the generic type of device pressure wedge for the reduction of cesarean delivery, and it is identified as a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery. 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—PRESSURE WEDGE FOR THE REDUCTION OF CESAREAN DELIVERY RISKS AND MITIGATION MEASURES Identified risk Mitigation measures Skin/tissue trauma .................................................................................... Non-clinical performance data, Clinical performance data, and Labeling. Non-clinical performance data and Labeling. sradovich on DSK3GMQ082PROD with RULES Device failure ............................................................................................ • Breakage. • Slippage. Infection .................................................................................................... Adverse tissue reaction ............................................................................ Pain ........................................................................................................... Use error ................................................................................................... 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. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply VerDate Sep<11>2014 16:07 Dec 27, 2017 Jkt 244001 Sterilization validation, Shelf life testing, and Labeling. Biocompatibility evaluation. Labeling. Labeling. 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, pressure wedge for the reduction of cesarean PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 delivery 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 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)). E:\FR\FM\28DER1.SGM 28DER1 61448 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Rules and Regulations 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. 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 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. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting materials must be evaluated to be biocompatible. (2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor. (3) Performance data must validate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life. (5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma. (6) The labeling must include: (i) Specific instructions regarding the proper placement and use of the device. (ii) A shelf life. Dated: December 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–28042 Filed 12–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 25 CFR Part 11 [189A2100DD/AAKC001030/A0A501010. 999900] List of Subjects in 21 CFR Part 884 RIN 1076–AF39 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 884 is amended as follows: Addition of the Wind River Indian Reservation to the List of Courts of Indian Offenses PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES SUMMARY: 1. The authority citation for part 884 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 884.5210 to subpart F to read as follows: ■ sradovich on DSK3GMQ082PROD with RULES § 884.5210 Pressure wedge for the reduction of cesarean delivery. (a) Identification. A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery. VerDate Sep<11>2014 16:07 Dec 27, 2017 Jkt 244001 Bureau of Indian Affairs, Interior. ACTION: Final rule; confirmation. AGENCY: The Bureau of Indian Affairs (BIA) is confirming the interim final rule published on October 27, 2016, establishing a Court of Indian Offenses (also known as a CFR Court) for the Wind River Indian Reservation. DATES: This final rule is effective on December 28, 2017. FOR FURTHER INFORMATION CONTACT: Ms. Elizabeth Appel, Director, Office of Regulatory Affairs & Collaborative Action—Indian Affairs, (202) 273–4680; elizabeth.appel@bia.gov. SUPPLEMENTARY INFORMATION: I. Summary of Rule II. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866) B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement Fairness Act PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 D. Unfunded Mandates Reform Act E. Takings (E.O. 12630) F. Federalism (E.O. 13132) G. Civil Justice Reform (E.O. 12988) H. Consultation With Indian Tribes (E.O. 13175 and Departmental Policy) I. Paperwork Reduction Act J. National Environmental Policy Act K. Effects on the Energy Supply (E.O. 13211) L. Clarity of This Regulation M. E.O. 13771: Reducing Regulation and Controlling Regulatory Costs I. Summary of Rule Generally, Courts of Indian Offenses operate in those areas of Indian country where Tribes retain jurisdiction over Indians that is exclusive of State jurisdiction, but where Tribal courts have not been established to fully exercise that jurisdiction. The Eastern Shoshone Tribe and the Northern Arapaho Tribe have an equal joint interest in the Wind River Indian Reservation. Since the publication of the Interim Final Rule establishing the Court of Indian Offenses for the Wind River Indian Reservation, the Shoshone & Arapaho Tribal Court has operated without the legal support of the Eastern Shoshone Tribe, and with limited resources. The Bureau has attempted to work with the Northern Arapaho Tribe towards establishing a system of courts with concurrent jurisdiction. However, after nine months of operation, the joint nature of the Wind River Indian Reservation has proven establishing such a system untenable. Allowing the Bureau of Indian Affairs to constitute a CFR Court will provide all residents on the Wind River Indian Reservation with comprehensive judicial services, and ensure the administration of justice and public safety. To accomplish this, this rule finalizes the revision of a section of 25 CFR part 11 to add the Wind River Indian Reservation in Wyoming to the list of areas in Indian country with established Courts of Indian Offenses (also known as CFR Courts). This rule inserts the Wind River Indian Reservation into a new paragraph (d) in 25 CFR 11.100. An interim final rule published on October 27, 2016 (81 FR 74675). Comments received on the interim final rule are addressed in Section II.H of this preamble, below. II. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866 and 13563) Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and E:\FR\FM\28DER1.SGM 28DER1

Agencies

[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Rules and Regulations]
[Pages 61446-61448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28042]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-6842]


Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Pressure Wedge for the Reduction of Cesarean 
Delivery

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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 December 28, 2017. The classification 
was applicable on December 19, 2016.

FOR FURTHER INFORMATION CONTACT: Mack Hall III, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3572, Silver Spring, MD 20993-0002, 301-796-5621, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the pressure wedge for the 
reduction of cesarean delivery 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

[[Page 61447]]

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 (21 U.S.C. 360c(f)(2)). 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 (21 U.S.C. 360c(a)(1)). Although the device 
was automatically 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 PMA 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 January 29, 2016, Stetrix, Inc., submitted a request for De Novo 
classification of the Hem-Avert[supreg] Perianal Stabilizer. 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 December 19, 2016, 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 884.5210. We have named 
the generic type of device pressure wedge for the reduction of cesarean 
delivery, and it is identified as a prescription device that provides 
external mechanical support to the perianal region during the labor and 
vaginal delivery process. External mechanical support of the perianal 
region is intended to help reduce the occurrence of cesarean delivery.
    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--Pressure Wedge for the Reduction of Cesarean Delivery Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Skin/tissue trauma.....................  Non-clinical performance data,
                                          Clinical performance data, and
                                          Labeling.
Device failure.........................  Non-clinical performance data
                                          and Labeling.
     Breakage..................
     Slippage..................
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Pain...................................  Labeling.
Use error..............................  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. In order 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, pressure wedge for the reduction of 
cesarean delivery 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 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)).

[[Page 61448]]

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. 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 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 884

    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 
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 continues to read as follows:

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


0
2. Add Sec.  884.5210 to subpart F to read as follows:


Sec.  884.5210   Pressure wedge for the reduction of cesarean delivery.

    (a) Identification. A pressure wedge for the reduction of cesarean 
delivery is a prescription device that provides external mechanical 
support to the perianal region during the labor and vaginal delivery 
process. External mechanical support of the perianal region is intended 
to help reduce the occurrence of cesarean delivery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be evaluated to be 
biocompatible.
    (2) Nonclinical performance data must demonstrate that the device 
will not break when subjected to the forces it will be exposed to 
during labor.
    (3) Performance data must validate the sterility of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility and package integrity over the 
labeled shelf life.
    (5) Clinical performance data must be provided that characterizes 
the rate of skin/tissue trauma.
    (6) The labeling must include:
    (i) Specific instructions regarding the proper placement and use of 
the device.
    (ii) A shelf life.

    Dated: December 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28042 Filed 12-27-17; 8:45 am]
 BILLING CODE 4164-01-P