83 FR 48711 - Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 188 (September 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 188 (September 27, 2018)
| Page Range | 48711-48714 | |
| FR Document | 2018-21044 |
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)] [Rules and Regulations] [Pages 48711-48714] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21044] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2017-N-6538] Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to ``single-use internal condom,'' a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for ``female condom,'' a preamendments class III device (product code OBY), by renaming the device ``multiple-use female condom,'' to distinguish it from the ``single-use internal condom.'' This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device. DATES: This order is effective October 29, 2018. FOR FURTHER INFORMATION CONTACT: Monica Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G215, Silver Spring, MD 20993, 240-402-2791, monica.garcia@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807. A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, 366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in ``medical science'' (Upjohn Co. v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether data before the Agency are old or new, the ``new information'' to support reclassification under section 513(f)(3) must be ``valid [[Page 48712]] scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.1985), cert. denied, 474 U.S. 1062 (1986)). FDA relies upon ``valid scientific evidence'' in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the ``valid scientific evidence'' upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section 520(h)(4) of the FD&C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device, but does not include descriptions of methods of manufacture or product composition and other trade secrets. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the 510(k) premarket notification requirements, if the Agency determines that premarket notification is not necessary to reasonably assure the safety and effectiveness of the device. On December 4, 2017, FDA published a proposed order in the Federal Register to reclassify the device (82 FR 57174) (the ``proposed order''). The period for public comment on the proposed order closed on February 2, 2018. FDA received and has considered 78 comments on the proposed order, as discussed in section II. II. Comments on the Proposed Order and FDA Response A. Introduction FDA received 78 public comments in response to the December 4, 2017, proposed order. These comments originated from individual consumers, academia, healthcare professionals, healthcare associations, local governments, and industry. The overwhelming majority of commenters supported the proposed reclassification, name change, and the general effort to increase patient access to single-use internal condoms. We describe and respond to the comments in section B, below. The order of response to the commenters is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. Certain comments are grouped together under a single number because the subject matter is similar. B. Description of Comments and FDA Response (Comment 1) Several commenters supported the reclassification and name change, but did not think a contraceptive effectiveness study should be required as a special control. These commenters believe that an acute failure modes study would be sufficient to ensure the safety and effectiveness of single-use internal condoms. The commenters indicated that requiring a contraceptive effectiveness study is burdensome and that the contraceptive effectiveness rate of a previously approved internal condom (FC1 Female Condom) should be leveraged in lieu of this special control. Another commenter suggested that single-use internal condoms be evaluated based on data from an acute failure modes study because this is the clinical evidence used to support clearance of male condoms made of synthetic materials. Finally, a different commenter agreed with FDA that there are unique considerations for the female condom, and that FDA should carefully consider each single-use internal condom to determine the appropriate method for clinical validation. The commenter noted that the majority of clinical studies published worldwide are conducted using male condoms, and that analysis by FDA, National Institutes of Health, and the Centers for Disease Control and Prevention re-confirmed the safety and effectiveness of male condoms. This commenter recommended that FDA consider developing a medical device development tool to find less burdensome ways of evaluating internal condom effectiveness using biomarkers. (Response 1) While the probable risks to health and risk mitigations are similar between male and single-use internal condoms, the failure modes are not the same between these two types of condoms. Male condoms have failure modes from slippage and breakage, while single-use internal condoms have failure modes that include slippage, breakage, misdirection, and invagination. FDA believes that a contraceptive effectiveness study is necessary to mitigate the risk of an undesired pregnancy because internal condoms have distinct design features from male condoms (e.g., internal and external retaining mechanisms) and from other internal condoms that can only be evaluated through a contraceptive effectiveness study. Accordingly, FDA believes that the clinical evidence from male condoms and other internal condoms cannot be leveraged to mitigate the risk of undesired pregnancy for an individual single-use internal condom. The contraceptive effectiveness rate of an individual internal condom is important because internal condoms are intended for the prevention of pregnancy, and this contraceptive effectiveness rate is important for consumers when deciding which method of contraception is most appropriate for them. FDA is not aware of any information, and none was provided to the docket, supporting that a biomarker method could be used in lieu of a contraceptive effectiveness study. (Comment 2) One commenter generally agreed with FDA's proposed reclassification, name change, and the proposed special controls for single-use internal condoms. This commenter stated that, in addition to FDA's proposed special controls, a pre-clearance good manufacturing practices (GMP) inspection should be required under section 513(f)(5) of the FD&C Act. (Response 2) FDA may withhold 510(k) clearance under section 513(f)(5) of the FD&C Act if there is a substantial likelihood that failure to comply with GMPs will potentially present a serious risk to human health. FDA does not believe the threshold for pre-clearance GMP inspections is met for single-use internal condoms. Single-use internal condoms will be required to comply with GMPs under the quality system regulation per 21 CFR part 820 that will, in part, mitigate the identified probable risks to health. FDA believes that the special controls identified in this final order, in addition to general controls, including compliance with GMPs, will provide reasonable assurance of safety and effectiveness for single-use internal condoms. (Comment 3) Multiple commenters requested that FDA not change contraceptive coverage policies for single-use internal condoms. (Response 3) Contraceptive coverage policies by private insurance payers and the Centers for Medicare & Medicaid Services are outside the scope of FDA's reclassification process. FDA is required to classify devices based on the regulatory controls necessary to provide reasonable assurance of device safety and effectiveness. FDA believes that sufficient information exists to establish special controls that, in addition to general controls, can provide reasonable assurance of safety and effectiveness for single-use internal condoms. [[Page 48713]] (Comment 4) Several comments received were related to consumer access and education. One commenter expressed concerns that consumers ``believe that all medical-like devices that are placed on the shelves have been reviewed and tested.'' Based on safety and effectiveness information provided to the docket, the commenter believes that more attention should be geared towards educating consumers on the proper use and effectiveness of single-use internal condoms. Conversely, several different commenters stated that single-use internal condoms should be made over-the-counter (OTC) devices. (Response 4) The single-use internal condom is not restricted to prescription use in accordance with 21 CFR 801.109. Single-use internal condoms are OTC devices because FDA believes that adequate directions for lay use can be developed in accordance with 21 CFR 801.5. Adequate directions for use are those under which the layman can use a device safely and for the purposes for which it is intended. This information helps consumers understand how to appropriately use the device and make informed decisions regarding its use. While the devices are OTC, single-use internal condoms will be subject to FDA premarket review in accordance with section 510(k) of the FD&C Act. In accordance with section 513(i) of the FD&C Act, FDA reviews appropriate clinical or scientific data as part of the substantial equivalence determination. (Comment 5) One commenter stated that single-use internal condoms should be class III ``based on medical evidence of its effectiveness in disease prevention as well as a safe and effective family planning method.'' The commenter believed that the reclassification is not based on science, that the reclassification is based on a political stance on birth control, and that science should be the only reason for reclassification. Three commenters included a combination of scientific literature, marketing data, non-public clinical data, and anecdotal information on one single-use internal condom used in the United States and another used outside the United States as additional evidence in support of FDA's reclassification. (Response 5) FDA is only authorized to use valid scientific evidence to support device reclassification, in accordance with 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). The commenter not supportive of the proposed reclassification did not provide specific information or rationales regarding why FDA's proposal to reclassify was not based on valid scientific evidence. As outlined in the proposed order, sufficient valid scientific evidence exists to establish special controls to provide reasonable assurance of the safety and effectiveness for single-use internal condoms, despite these condoms being for a use which is of substantial importance in preventing impairment of human health. Therefore, FDA believes that single-use internal condoms meet the statutory definition of class II (special controls). (Comment 6) One commenter requested clarification regarding differences in how male condoms are regulated in comparison to single- use internal condoms. (Response 6) A male condom is comprised of a sheath which completely covers the penis with a closely fitting membrane. Male condoms are regulated under 21 CFR 884.5300 and are class II (special controls). As of the effective date of this reclassification order, single-use internal condoms are class II (special controls). FDA has identified distinct special controls for single-use internal condoms because they have different failure modes due to differences in technological characteristics compared to male condoms. III. The Final Order FDA is adopting its findings under section 513(f)(3) of the FD&C Act, as published in the preamble to the proposed order (82 FR 57174). FDA is issuing this final order to reclassify single-use female condoms from class III to class II, rename them ``single-use internal condoms,'' and establish special controls by revising 21 CFR part 884. In this final order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls, provide a reasonable assurance of the safety and effectiveness for single-use internal condoms. FDA is also amending the existing device identification for female condoms to distinguish them from single-use internal condoms, by renaming the device ``multiple-use female condom.'' The Agency is making two minor modifications to the identification for single-use internal condoms by confirming that they are OTC devices and that the device is intended to ``prevent the transmission of sexually transmitted infections,'' not ``prevent sexually transmitted infections.'' FDA may exempt a class II device from the premarket notification requirements, under section 510(m) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the devices. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of single-use internal condoms, and therefore, this device type is not exempt from premarket notification requirements. The device is assigned the generic name single-use internal condom, and it is identified as an OTC sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. Under this final order, the single-use internal condom is an OTC device. OTC devices must bear adequate directions for lay use as outlined in 21 CFR 801.5. Under 21 CFR 807.81, the device would continue to be subject to 510(k) requirements. IV. Analysis of Environmental Impact We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. V. Paperwork Reduction Act of 1995 This final administrative 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 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information under 21 CFR part 801 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: [[Page 48714]] 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. Amend Sec. 884.5330 by revising the section heading and paragraph (a) to read as follows: Sec. 884.5330 Multiple-use female condom. (a) Identification. A multiple-use female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. At the conclusion of coitus, the device can be reused. It is indicated for contraception and prophylactic (preventing the transmission of sexually transmitted infections) purposes. * * * * * 0 3. Add Sec. 884.5340 to subpart F to read as follows: Sec. 884.5340 Single-use internal condom. (a) Identification. A single-use internal condom is an over-the- counter sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must evaluate the following: (i) Rate of clinical failure of the device and rate of individual failure modes of the device based on an acute failure modes study evaluating the intended use (vaginal and/or anal intercourse); and (ii) Cumulative pregnancy rate when using the device based on a contraceptive effectiveness study (when the device is indicated for vaginal intercourse). (2) Viral penetration testing must demonstrate the device is an effective barrier to sexually transmitted infections. (3) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Mechanical testing must demonstrate the device can withstand forces under anticipated use conditions, include evaluation of tensile, tear, and burst properties of the device; and (ii) Compatibility testing with personal lubricants must determine whether the physical properties of the device are adversely affected by use of additional lubricants. (4) The device must be demonstrated to be biocompatible. (5) Shelf-life testing must demonstrate that the device maintains its performance characteristics and the packaging of the device must maintain integrity for the duration of the shelf-life. (6) Labeling of the device must include: (i) Contraceptive effectiveness table comparing typical use and perfect use pregnancy rates with the device to other available methods of birth control; (ii) Statement regarding the adverse events associated with the device, including potential transmission of infection, adverse tissue reaction, and ulceration or other physical trauma; (iii) Expiration date; and (iv) Statement regarding compatibility with additional types of personal lubricants. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21044 Filed 9-26-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Rules and Regulations 48711
(2) Accomplishment of the actions required the availability of this material at NARA, call SUPPLEMENTARY INFORMATION:
by paragraph (g) of this AD terminates the 202–741–6030, or go to: http://
requirements of paragraph (h) of AD 2013– www.archives.gov/federal-register/cfr/ibr- I. Background
24–07. locations.html. The Federal Food, Drug, and Cosmetic
(k) Alternative Methods of Compliance Issued in Des Moines, Washington, on Act (FD&C Act), as amended, establishes
(AMOCs) September 10, 2018. a comprehensive system for the
(1) The Manager, Los Angeles ACO Branch, Michael Kaszycki, regulation of medical devices intended
FAA, has the authority to approve AMOCs Acting Director, System Oversight Division, for human use. Section 513 of the FD&C
for this AD, if requested using the procedures Aircraft Certification Service. Act (21 U.S.C. 360c) established three
found in 14 CFR 39.19. In accordance with [FR Doc. 2018–20631 Filed 9–26–18; 8:45 am] categories (classes) of devices, reflecting
14 CFR 39.19, send your request to your the regulatory controls needed to
BILLING CODE 4910–13–P
principal inspector or local Flight Standards provide reasonable assurance of their
District Office, as appropriate. If sending
safety and effectiveness. The three
information directly to the manager of the
certification office, send it to the attention of DEPARTMENT OF HEALTH AND categories of devices are class I (general
the person identified in paragraph (l) of this HUMAN SERVICES controls), class II (special controls), and
AD. Information may be emailed to: 9-AWP- class III (premarket approval).
LAACO-ADS@faa.gov. Food and Drug Administration Devices that were not in commercial
(2) Before using any approved AMOC, distribution prior to May 28, 1976
notify your appropriate principal inspector, 21 CFR Part 884 (generally referred to as
or lacking a principal inspector, the manager postamendments devices) are
of the local flight standards district office/ [Docket No. FDA–2017–N–6538] automatically classified by section
certificate holding district office. 513(f)(1) of the FD&C Act into class III
(3) An AMOC that provides an acceptable Obstetrical and Gynecological
level of safety may be used for any repair, Devices; Reclassification of Single-Use without any FDA rulemaking process.
modification, or alteration required by this Female Condom, To Be Renamed Those devices remain in class III and
AD if it is approved by the Boeing Single-Use Internal Condom require premarket approval unless, and
Commercial Airplanes Organization until, the device is reclassified into class
Designation Authorization (ODA) that has AGENCY: Food and Drug Administration, I or II, or FDA issues an order finding
been authorized by the Manager, Los Angeles HHS. the device to be substantially
ACO Branch, to make those findings. To be ACTION: Final order. equivalent, in accordance with section
approved, the repair method, modification 513(i) of the FD&C Act, to a predicate
deviation, or alteration deviation must meet The Food and Drug
SUMMARY: device that does not require premarket
the certification basis of the airplane, and theAdministration (FDA or the Agency) is
approval must specifically refer to this AD.
approval. The Agency determines
issuing a final order to reclassify single- whether new devices are substantially
(l) Related Information use female condoms, renaming the equivalent to predicate devices by
For more information about this AD, device to ‘‘single-use internal condom,’’ means of premarket notification
contact Samuel Lee, Aerospace Engineer, a postamendments class III device procedures in section 510(k) of the
Propulsion Section, FAA, Los Angeles ACO (regulated under product code MBU), FD&C Act (21 U.S.C. 360(k)) and 21 CFR
Branch, 3960 Paramount Boulevard, into class II (special controls) subject to part 807.
Lakewood, CA 90712–4137; phone: 562–627– premarket notification (510(k)). FDA is A postamendments device that has
5262; fax: 562–627–5210; email: samuel.lee@ also identifying the special controls that been initially classified in class III
faa.gov. the Agency believes are necessary to under section 513(f)(1) of the FD&C Act
(m) Material Incorporated by Reference provide a reasonable assurance of safety may be reclassified into class I or class
(1) The Director of the Federal Register and effectiveness of the device. FDA is II under section 513(f)(3) of the FD&C
approved the incorporation by reference finalizing this reclassification on its Act. Section 513(f)(3) of the FD&C Act
(IBR) of the service information listed in this own initiative based on new provides that FDA acting by order can
paragraph under 5 U.S.C. 552(a) and 1 CFR information. FDA is also amending the reclassify the device into class I or class
part 51. existing device identification for II on its own initiative, or in response
(2) You must use this service information ‘‘female condom,’’ a preamendments
as applicable to do the actions required by
to a petition from the manufacturer or
class III device (product code OBY), by importer of the device. To change the
this AD, unless the AD specifies otherwise.
renaming the device ‘‘multiple-use classification of the device, the
(i) Boeing 707/720 Airworthiness
Limitations (AWLs), D6–7552–AWL, dated female condom,’’ to distinguish it from proposed new class must have sufficient
October 2016. (Subsection A.2 of this the ‘‘single-use internal condom.’’ This regulatory controls to provide
document includes pages 33 and 34, which order reclassifies single-use internal reasonable assurance of the safety and
are not identified in the Table of Contents.) condoms from class III to class II and effectiveness of the device for its
(ii) Reserved. reduces regulatory burden because these intended use.
(3) For service information identified in types of devices will no longer be Reevaluation of the data previously
this AD, contact Boeing Commercial required to submit a premarket approval
Airplanes, Attention: Contractual & Data
before the Agency is an appropriate
application (PMA), but can instead basis for subsequent action where the
Services (C&DS), 2600 Westminster Blvd.,
MC 110–SK57, Seal Beach, CA 90740–5600;
submit a less burdensome 510(k) before reevaluation is made in light of newly
telephone: 562–797–1717; internet: https:// marketing their device. available regulatory authority (see Bell
www.myboeingfleet.com. DATES: This order is effective October v. Goddard, 366 F.2d 177, 181 (7th Cir.
(4) You may view this service information 29, 2018. 1966); Ethicon, Inc. v. FDA, 762 F.
at the FAA, Transport Standards Branch, FOR FURTHER INFORMATION CONTACT: Supp. 382, 388–391 (D.D.C. 1991)), or in
daltland on DSKBBV9HB2PROD with RULES
2200 South 216th St., Des Moines, WA. For Monica Garcia, Center for Devices and light of changes in ‘‘medical science’’
information on the availability of this
material at the FAA, call 206–231–3195.
Radiological Health, Food and Drug (Upjohn Co. v. Finch, 422 F.2d 944, 951
(5) You may view this service information Administration, 10903 New Hampshire (6th Cir. 1970)). Whether data before the
that is incorporated by reference at the Ave., Bldg. 66, Rm. G215, Silver Spring, Agency are old or new, the ‘‘new
National Archives and Records MD 20993, 240–402–2791, information’’ to support reclassification
Administration (NARA). For information on monica.garcia@fda.hhs.gov. under section 513(f)(3) must be ‘‘valid
VerDate Sep<11>2014 16:04 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\27SER1.SGM 27SER1](https://thefederalregister.org/doc/83_FR_48899/page/1.svg)
![48714 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Rules and Regulations
PART 884—OBSTETRICAL AND (ii) Compatibility testing with Docket Folder on the line associated
GYNECOLOGICAL DEVICES personal lubricants must determine with this deviation.
whether the physical properties of the FOR FURTHER INFORMATION CONTACT: If
■ 1. The authority citation for part 884 device are adversely affected by use of you have questions on this temporary
continues to read as follows: additional lubricants. deviation, call or email Judy Leung-Yee,
Authority: 21 U.S.C. 351, 360, 360c, 360e, (4) The device must be demonstrated
Bridge Management Specialist, First
360j, 360l, 371. to be biocompatible.
District Bridge Branch, U.S. Coast
(5) Shelf-life testing must demonstrate
■ 2. Amend § 884.5330 by revising the Guard, telephone 212–514–4336, email
that the device maintains its
section heading and paragraph (a) to Judy.K.Leung-Yee@uscg.mil.
performance characteristics and the
read as follows: SUPPLEMENTARY INFORMATION: The owner
packaging of the device must maintain
§ 884.5330 Multiple-use female condom. integrity for the duration of the shelf- of the bridge, Consolidated Rail
(a) Identification. A multiple-use life. Corporation, requested a temporary
female condom is a sheath-like device (6) Labeling of the device must deviation from the normal operating
that lines the vaginal wall and is include: schedule to replace bridge timber on the
inserted into the vagina prior to the (i) Contraceptive effectiveness table lift span. The Lehigh Valley Bridge
initiation of coitus. At the conclusion of comparing typical use and perfect use across the Newark Bay, mile 4.3, at
coitus, the device can be reused. It is pregnancy rates with the device to other Newark, New Jersey is a lift bridge with
indicated for contraception and available methods of birth control; a vertical clearance in the closed
(ii) Statement regarding the adverse position of 35 feet at mean high water
prophylactic (preventing the
events associated with the device, and 39 feet at mean low water. The
transmission of sexually transmitted
including potential transmission of existing bridge operating regulations are
infections) purposes.
infection, adverse tissue reaction, and listed at §§ 117.5 and 117.735.
* * * * * ulceration or other physical trauma; Under this temporary deviation, the
■ 3. Add § 884.5340 to subpart F to read (iii) Expiration date; and Lehigh Valley Bridge shall remain in the
as follows: (iv) Statement regarding compatibility closed position from 6 a.m. on October
with additional types of personal 14, 2018 to 6 p.m. on October 15, 2018;
§ 884.5340 Single-use internal condom.
lubricants. from 6 a.m. on October 21 to 6 p.m. on
(a) Identification. A single-use
internal condom is an over-the-counter Dated: September 21, 2018. October 22, 2018; and from 6 a.m. on
sheath-like device that lines the vaginal Leslie Kux, October 28, 2018 to 6 p.m. on October
or anal wall and is inserted into the Associate Commissioner for Policy. 29, 2018. Should inclement weather
vagina or anus prior to the initiation of [FR Doc. 2018–21044 Filed 9–26–18; 8:45 am] occur, the following rain dates may be
coitus. At the conclusion of coitus, it is BILLING CODE 4164–01–P
used: (a) From 6 a.m. on November 4,
removed and discarded. It is indicated 2018 to 6 p.m. on November 5, 2018; or
for contraception and/or prophylactic (b) from 6 a.m. on November 11, 2018
(preventing the transmission of sexually DEPARTMENT OF HOMELAND to 6 p.m. on November 12, 2018.
transmitted infections) purposes. SECURITY The waterway is transited by
(b) Classification. Class II (special recreational and commercial vessels.
controls). The special controls for this Coast Guard Coordination with known waterway
device are: users has indicated no objection to the
(1) Clinical performance testing must 33 CFR Part 117 closure. Vessels able to pass through the
evaluate the following: bridge in the closed position may do so
[Docket No. USCG–2018–0836]
(i) Rate of clinical failure of the device at anytime. The bridge will not be able
and rate of individual failure modes of Drawbridge Operation Regulation; to open for emergencies and there is no
the device based on an acute failure Newark Bay, Newark, NJ immediate alternate route for vessels to
modes study evaluating the intended pass.
use (vaginal and/or anal intercourse); AGENCY: Coast Guard, DHS. The Coast Guard will inform the users
and ACTION:Notice of deviation from of the waterways through our Local and
(ii) Cumulative pregnancy rate when drawbridge regulation. Broadcast Notices to Mariners of the
using the device based on a change in operating schedule for the
contraceptive effectiveness study (when SUMMARY: The Coast Guard has issued a
bridge so that vessel operators can
the device is indicated for vaginal temporary deviation from the operating
arrange their transits to minimize any
intercourse). schedule that governs the Lehigh Valley
impact caused by the temporary
(2) Viral penetration testing must Bridge across the Newark Bay, mile 4.3,
deviation.
demonstrate the device is an effective at Newark, New Jersey. The deviation is
necessary to replace bridge timber on In accordance with 33 CFR 117.35(e),
barrier to sexually transmitted the drawbridge must return to its regular
infections. the lift span. This deviation allows the
bridge to remain in the closed-to operating schedule immediately at the
(3) Nonclinical performance testing end of the effective period of this
must demonstrate that the device navigation position during the
construction periods. temporary deviation. This deviation
performs as intended under anticipated from the operating regulations is
conditions of use. The following DATES: This deviation is effective from
6 a.m. on October 14, 2018, to 6 p.m. on authorized under 33 CFR 117.35.
performance characteristics must be
daltland on DSKBBV9HB2PROD with RULES
evaluated: November 12, 2018. Dated: September 21, 2018.
(i) Mechanical testing must ADDRESSES: The docket for this C.J. Bisignano,
demonstrate the device can withstand deviation, USCG–2018–0836 is available Supervisory Bridge Management Specialist,
forces under anticipated use conditions, at http://www.regulations.gov. Type the First Coast Guard District.
include evaluation of tensile, tear, and docket number in the ‘‘SEARCH’’ box [FR Doc. 2018–21049 Filed 9–26–18; 8:45 am]
burst properties of the device; and and click ‘‘SEARCH.’’ Click on Open BILLING CODE 9110–04–P
VerDate Sep<11>2014 16:04 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4700 Sfmt 9990 E:\FR\FM\27SER1.SGM 27SER1](https://thefederalregister.org/doc/83_FR_48899/page/4.svg)
Document Created: 2018-09-27 01:04:32
Document Modified: 2018-09-27 01:04:32
| 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 October 29, 2018. | |
| Contact | Monica Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G215, Silver Spring, MD 20993, 240-402-2791, [email protected] | |
| FR Citation | 83 FR 48711 |
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