82 FR 61446 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 248 (December 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 248 (December 28, 2017)
| Page Range | 61446-61448 | |
| FR Document | 2017-28042 |
[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)] [Rules and Regulations] [Pages 61446-61448] From the Federal Register Online [www.thefederalregister.org] [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
![61446 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Rules and Regulations
Therefore, under the Federal Food, Veterinary Medicine, the investigator DEPARTMENT OF HEALTH AND
Drug, and Cosmetic Act and under will be given an opportunity for a HUMAN SERVICES
authority delegated to the Commissioner regulatory hearing under part 16 of this
of Food and Drugs, 21 CFR parts 16 and chapter on the question of whether the Food and Drug Administration
511 are amended as follows: investigator is eligible to receive test
articles under this part and eligible to 21 CFR Part 884
PART 16—REGULATORY HEARING conduct: [Docket No. FDA–2017–N–6842]
BEFORE THE FOOD AND DRUG
ADMINISTRATION (i) Any clinical investigation that
supports an application for a research or Medical Devices; Obstetrical and
1. The authority citation for part 16 Gynecological Devices; Classification
■ marketing permit for products regulated
continues to read as follows: of the Pressure Wedge for the
by FDA; and
Reduction of Cesarean Delivery
Authority: 15 U.S.C. 1451–1461; 21 U.S.C. (ii) Any nonclinical laboratory study
141–149, 321–394, 467f, 679, 821, 1034; 28 intended to support an application for a AGENCY: Food and Drug Administration,
U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. HHS.
research or marketing permit for a new
■ 2. In § 16.1, in paragraph (b)(2), revise animal drug. ACTION: Final order.
the numerically sequenced entry for (2) * * * The notification also will
§ 511.1(c)(1) to read as follows: SUMMARY: The Food and Drug
explain that an investigator determined Administration (FDA or we) is
§ 16.1 Scope. to be ineligible to receive test articles classifying the pressure wedge for the
* * * * * under this part will be ineligible to reduction of cesarean delivery into class
(b) * * * conduct: II (special controls). The special controls
(2) * * * (i) Any clinical investigation that that apply to the device type are
(c)(1), relating to whether an supports an application for a research or identified in this order and will be part
investigator is eligible to receive test marketing permit for products regulated of the codified language for the pressure
articles under part 511 of this chapter by FDA, including drugs, biologics, wedge for the reduction of cesarean
and eligible to conduct any clinical devices, new animal drugs, foods, delivery’s classification. We are taking
investigation that supports an including dietary supplements, that bear this action because we have determined
application for a research or marketing that classifying the device into class II
a nutrient content claim or a health
permit for products regulated by FDA (special controls) will provide a
claim, infant formulas, food and color
including drugs, biologics, devices, new reasonable assurance of safety and
animal drugs, foods, including dietary additives, and tobacco products; and effectiveness of the device. We believe
supplements, that bear a nutrient (ii) Any nonclinical laboratory study this action will also enhance patients’
content claim or a health claim, infant intended to support an application for a access to beneficial innovative devices,
formulas, food and color additives, and research or marketing permit for a new in part by reducing regulatory burdens.
tobacco products; and any nonclinical animal drug. DATES: This order is effective December
laboratory study intended to support an * * * * * 28, 2017. The classification was
application for a research or marketing applicable on December 19, 2016.
permit for a new animal drug. (6) An investigator who has been
determined to be ineligible under FOR FURTHER INFORMATION CONTACT:
* * * * * Mack Hall III, Center for Devices and
paragraph (c)(2) of this section may be
reinstated as eligible when the Radiological Health, Food and Drug
PART 511—NEW ANIMAL DRUGS FOR Administration, 10903 New Hampshire
INVESTIGATIONAL USE Commissioner determines that the
investigator has presented adequate Ave., Bldg. 66, Rm. 3572, Silver Spring,
■ 3. The authority citation for part 511 assurances that the investigator will MD 20993–0002, 301–796–5621,
continues to read as follows: mack.hall@fda.hhs.gov.
employ all test articles, and will
conduct any clinical investigation that SUPPLEMENTARY INFORMATION:
Authority: 21 U.S.C. 321, 351, 352, 353,
360b, 371. supports an application for a research or I. Background
■ 4. In § 511.1: marketing permit for products regulated
Upon request, FDA has classified the
■ a. Revise the section heading; by FDA and any nonclinical laboratory
pressure wedge for the reduction of
■ b. Revise the last sentence in study intended to support an cesarean delivery as class II (special
paragraph (c)(1); application for a research or marketing controls), which we have determined
■ c. Add paragraphs (c)(1)(i) and (ii); permit for a new animal drug, solely in will provide a reasonable assurance of
■ d. Revise the last sentence in compliance with the applicable safety and effectiveness. In addition, we
paragraph (c)(2); provisions of this chapter. believe this action will enhance
■ e. Add paragraphs (c)(2)(i) and (ii);
* * * * * patients’ access to beneficial innovation,
and in part by reducing regulatory burdens
■ f. Revise paragraph (c)(6). Dated: December 21, 2017.
by placing the device into a lower
The revisions and additions read as Leslie Kux,
device class than the automatic class III
follows: Associate Commissioner for Policy. assignment.
§ 511.1 New animal drugs for [FR Doc. 2017–27973 Filed 12–27–17; 8:45 am] The automatic assignment of class III
sradovich on DSK3GMQ082PROD with RULES
investigational use exempt from section BILLING CODE 4164–01–P occurs by operation of law and without
512(a) of the Federal Food, Drug, and any action by FDA, regardless of the
Cosmetic Act. level of risk posed by the new device.
* * * * * Any device that was not in commercial
(c) * * * distribution before May 28, 1976, is
(1) * * * If an explanation is offered automatically classified as, and remains
but not accepted by the Center for within, class III and requires premarket
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![61448 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Rules and Regulations
III. Analysis of Environmental Impact (b) Classification. Class II (special D. Unfunded Mandates Reform Act
controls). The special controls for this E. Takings (E.O. 12630)
The Agency has determined under 21 F. Federalism (E.O. 13132)
device are:
CFR 25.34(b) that this action is of a type G. Civil Justice Reform (E.O. 12988)
(1) The patient contacting materials H. Consultation With Indian Tribes (E.O.
that does not individually or
must be evaluated to be biocompatible. 13175 and Departmental Policy)
cumulatively have a significant effect on
(2) Nonclinical performance data I. Paperwork Reduction Act
the human environment. Therefore,
must demonstrate that the device will J. National Environmental Policy Act
neither an environmental assessment
not break when subjected to the forces K. Effects on the Energy Supply (E.O.
nor an environmental impact statement 13211)
it will be exposed to during labor.
is required. L. Clarity of This Regulation
(3) Performance data must validate
M. E.O. 13771: Reducing Regulation and
IV. Paperwork Reduction Act of 1995 the sterility of the device.
Controlling Regulatory Costs
(4) Performance data must support the
This final order establishes special shelf life of the device by demonstrating I. Summary of Rule
controls that refer to previously continued sterility and package integrity
approved collections of information Generally, Courts of Indian Offenses
over the labeled shelf life. operate in those areas of Indian country
found in other FDA regulations. These (5) Clinical performance data must be
collections of information are subject to where Tribes retain jurisdiction over
provided that characterizes the rate of Indians that is exclusive of State
review by the Office of Management and skin/tissue trauma.
Budget (OMB) under the Paperwork jurisdiction, but where Tribal courts
(6) The labeling must include: have not been established to fully
Reduction Act of 1995 (44 U.S.C. 3501– (i) Specific instructions regarding the
3520). The collections of information in exercise that jurisdiction. The Eastern
proper placement and use of the device. Shoshone Tribe and the Northern
the guidance document ‘‘De Novo (ii) A shelf life.
Classification Process (Evaluation of Arapaho Tribe have an equal joint
Automatic Class III Designation)’’ have Dated: December 22, 2017. interest in the Wind River Indian
been approved under OMB control Leslie Kux, Reservation. Since the publication of the
number 0910–0844; the collections of Associate Commissioner for Policy. Interim Final Rule establishing the
information in part 814, subparts A Court of Indian Offenses for the Wind
[FR Doc. 2017–28042 Filed 12–27–17; 8:45 am]
through E, regarding premarket River Indian Reservation, the Shoshone
BILLING CODE 4164–01–P
approval, have been approved under & Arapaho Tribal Court has operated
OMB control number 0910–0231; the without the legal support of the Eastern
Shoshone Tribe, and with limited
collections of information in part 807, DEPARTMENT OF THE INTERIOR resources. The Bureau has attempted to
subpart E, regarding premarket
work with the Northern Arapaho Tribe
notification submissions, have been Bureau of Indian Affairs towards establishing a system of courts
approved under OMB control number
with concurrent jurisdiction. However,
0910–0120, and the collections of 25 CFR Part 11 after nine months of operation, the joint
information in 21 CFR part 801,
[189A2100DD/AAKC001030/A0A501010. nature of the Wind River Indian
regarding labeling, have been approved
999900] Reservation has proven establishing
under OMB control number 0910–0485.
such a system untenable.
RIN 1076–AF39
List of Subjects in 21 CFR Part 884 Allowing the Bureau of Indian Affairs
Addition of the Wind River Indian to constitute a CFR Court will provide
Medical devices. all residents on the Wind River Indian
Reservation to the List of Courts of
Therefore, under the Federal Food, Reservation with comprehensive
Indian Offenses
Drug, and Cosmetic Act and under judicial services, and ensure the
authority delegated to the Commissioner AGENCY: Bureau of Indian Affairs, administration of justice and public
of Food and Drugs, 21 CFR part 884 is Interior. safety. To accomplish this, this rule
amended as follows: ACTION: Final rule; confirmation. finalizes the revision of a section of 25
CFR part 11 to add the Wind River
PART 884—OBSTETRICAL AND SUMMARY: The Bureau of Indian Affairs Indian Reservation in Wyoming to the
GYNECOLOGICAL DEVICES (BIA) is confirming the interim final list of areas in Indian country with
rule published on October 27, 2016, established Courts of Indian Offenses
■ 1. The authority citation for part 884 establishing a Court of Indian Offenses (also known as CFR Courts). This rule
continues to read as follows: (also known as a CFR Court) for the inserts the Wind River Indian
Authority: 21 U.S.C. 351, 360, 360c, 360e, Wind River Indian Reservation. Reservation into a new paragraph (d) in
360j, 360l, 371. DATES: This final rule is effective on 25 CFR 11.100.
December 28, 2017. An interim final rule published on
■ 2. Add § 884.5210 to subpart F to read
FOR FURTHER INFORMATION CONTACT: Ms.
October 27, 2016 (81 FR 74675).
as follows:
Elizabeth Appel, Director, Office of Comments received on the interim final
§ 884.5210 Pressure wedge for the Regulatory Affairs & Collaborative rule are addressed in Section II.H of this
reduction of cesarean delivery.
Action—Indian Affairs, (202) 273–4680; preamble, below.
(a) Identification. A pressure wedge elizabeth.appel@bia.gov. II. Procedural Requirements
for the reduction of cesarean delivery is SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with RULES
a prescription device that provides A. Regulatory Planning and Review
external mechanical support to the I. Summary of Rule (E.O. 12866 and 13563)
II. Procedural Requirements
perianal region during the labor and A. Regulatory Planning and Review (E.O.
Executive Order 12866 provides that
vaginal delivery process. External 12866) the Office of Information and Regulatory
mechanical support of the perianal B. Regulatory Flexibility Act Affairs in the Office of Management and
region is intended to help reduce the C. Small Business Regulatory Enforcement Budget will review all significant rules.
occurrence of cesarean delivery. Fairness Act The Office of Information and
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Document Created: 2017-12-28 00:44:28
Document Modified: 2017-12-28 00:44:28
| 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 December 28, 2017. The classification was applicable on December 19, 2016. | |
| 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] | |
| FR Citation | 82 FR 61446 |
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