81 FR 378 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 3 (January 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 3 (January 6, 2016)
| Page Range | 378-380 | |
| FR Document | 2015-33264 |
[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)] [Rules and Regulations] [Pages 378-380] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-33264] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2015-N-4408] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective January 6, 2015. The classification was applicable on November 2, 2015. FOR FURTHER INFORMATION CONTACT: Jason Roberts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6400, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or 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 part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&CAct, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On February 23, 2015, INVO Bioscience, submitted a request for classification of the INVOcellTM Intravaginal Culture System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on November 2, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding Sec. 884.6165 (21 CFR 884.6165). Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an intravaginal culture system will need to comply with the special controls named in this final order. The device is assigned the generic name intravaginal culture system, and it is identified as a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization (IVF) or intravaginal culture procedures. FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1: [[Page 379]] Table 1--Intravaginal Culture System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Damage to gametes and/or Nonclinical performance testing. embryos or disruption of the Shelf life testing. IVF process. Clinical testing. Sterilization validation. Labeling. Patient injury (e.g., Nonclinical performance testing. hypersensitivity, toxicity, Shelf life testing. abrasion, discomfort). Biocompatibility. Clinical testing. Sterilization validation. Labeling. Infection.................... Sterilization validation. Reprocessing validation. Nonclinical performance testing. Shelf life testing. Clinical testing. Labeling. Transfer of incorrect embryos Labeling. to patient. ------------------------------------------------------------------------ FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Intravaginal culture system devices are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (Prescription devices). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the intravaginal culture system they intend to market. II. Environmental Impact, No Significant 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. III. 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 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. IV. Reference The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. 1. DEN150008: De novo Request per 513(f)(2) from INVO Bioscience, dated February 23, 2015. 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 21 CFR part 884 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 884.6165 to subpart G to read as follows: Sec. 884.6165 Intravaginal culture system. (a) Identification. An intravaginal culture system is a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate the following: (i) Comfort and retention of the intravaginal culture device; (ii) Adverse vaginal tissue reactions associated with intravaginal culture; (iii) Maximum number of gametes and/or embryos that can be placed in a device; and (iv) Rates of embryo development to the designated stage, implantation rates, clinical pregnancy rates, live birth rates, and any adverse events or outcomes. (2) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Mouse embryo assay testing to assess embryotoxicity by evaluating the gamete and embryo-contacting device components effect on the growth and development of mouse embryos to the blastocyst stage; (ii) Endotoxin testing on gamete and embryo-contacting components of the device; (iii) Cleaning and disinfection validation of reusable device components; (iv) Sterility maintenance of the culture media within the device throughout the vaginal incubation [[Page 380]] period and subsequent embryo extraction; and (v) Ability of the device to permit oxygen and carbon dioxide exchange between the media contained within the device and the external environment throughout the vaginal incubation period. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (5) Shelf life testing must demonstrate that the device maintains its performance characteristics and the packaging of device components labeled as sterile maintain integrity and sterility for the duration of the shelf life. (6) Labeling for the device must include: (i) A detailed summary of the clinical testing, including device effectiveness, device-related complications, and adverse events; (ii) Validated methods and instructions for reprocessing of reusable components; (iii) The maximum number of gametes or embryos that can be loaded into the device; (iv) A warning that informs users that the embryo development is first evaluated following intravaginal culture; and (v) A statement that instructs the user to use legally marketed assisted reproductive technology media that contain elements to mitigate the contamination risk (e.g., antibiotics) and to support continued embryonic development over the intravaginal culture period. (7) Patient labeling must be provided and must include: (i) Relevant warnings, precautions, and adverse effects and complications; (ii) Information on how to use the device; (iii) The risks and benefits associated with the use of the device; and (iv) A summary of the principal clinical device effectiveness results. Dated: December 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-33264 Filed 1-5-16; 8:45 am] BILLING CODE 4164-01-P
![378 Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Rules and Regulations
Amendment Number 6 Effective Date: Radiological Health, Food and Drug the device or if FDA determines that the
August 17, 2009. Administration, 10903 New Hampshire device submitted is not of ‘‘low-
Amendment Number 7 Effective Date: Ave., Bldg. 66, Rm. G218, Silver Spring, moderate risk’’ or that general controls
December 28, 2009. MD 20993–0002, 240–402–6400, would be inadequate to control the risks
Amendment Number 8 Effective Date: jason.roberts@fda.hhs.gov. and special controls to mitigate the risks
May 2, 2012, as corrected on November SUPPLEMENTARY INFORMATION: cannot be developed.
16, 2012 (ADAMS Accession No.
I. Background In response to a request to classify a
ML12213A170).
device under either procedure provided
Amendment Number 9 Effective Date: In accordance with section 513(f)(1) of by section 513(f)(2) of the FD&C Act,
March 11, 2014, superseded by the Federal Food, Drug, and Cosmetic FDA will classify the device by written
Amendment Number 9, Revision 1, on Act (the FD&C Act) (21 U.S.C. order within 120 days. This
March 21, 2016. 360c(f)(1)), devices that were not in
xxxx classification will be the initial
commercial distribution before May 28, classification of the device.
Amendment Number 9, Revision 1, 1976 (the date of enactment of the
Effective Date: March 21, 2016. Medical Device Amendments of 1976), On February 23, 2015, INVO
Safety Analysis Report (SAR) generally referred to as postamendments Bioscience, submitted a request for
Submitted by: Holtec International. devices, are classified automatically by classification of the INVOcellTM
SAR Title: Final Safety Analysis statute into class III without any FDA Intravaginal Culture System under
Report for the HI–STORM 100 Cask rulemaking process. These devices section 513(f)(2) of the FD&C Act. The
System. remain in class III and require manufacturer recommended that the
Docket Number: 72–1014. device be classified into class II (Ref. 1).
Certificate Expiration Date: May 31, premarket approval, unless and until
2020. the device is classified or reclassified In accordance with section 513(f)(2) of
Model Number: HI–STORM 100. into class I or II, or FDA issues an order the FD&C Act, FDA reviewed the
finding the device to be substantially request for de novo classification in
* * * * *
equivalent, in accordance with section order to classify the device under the
Dated at Rockville, Maryland, this 22nd 513(i) of the FD&C Act, to a predicate criteria for classification set forth in
day of December, 2015. device that does not require premarket section 513(a)(1). FDA classifies devices
For the Nuclear Regulatory Commission. approval. The Agency determines into class II if general controls by
Glenn M. Tracy, whether new devices are substantially themselves are insufficient to provide
Acting, Executive Director for Operations. equivalent to predicate devices by reasonable assurance of safety and
[FR Doc. 2015–33280 Filed 1–5–16; 8:45 am] means of premarket notification effectiveness, but there is sufficient
BILLING CODE 7590–01–P procedures in section 510(k) of the information to establish special controls
FD&C Act (21 U.S.C. 360(k)) and part to provide reasonable assurance of the
807 (21 CFR part 807) of the regulations. safety and effectiveness of the device for
DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as its intended use. After review of the
HUMAN SERVICES amended by section 607 of the Food and information submitted in the request,
Drug Administration Safety and FDA determined that the device can be
Food and Drug Administration Innovation Act (Pub. L. 112–144), classified into class II with the
provides two procedures by which a establishment of special controls. FDA
21 CFR Part 884 person may request FDA to classify a believes these special controls, in
device under the criteria set forth in addition to general controls, will
[Docket No. FDA–2015–N–4408] section 513(a)(1). Under the first provide reasonable assurance of the
Medical Devices; Obstetrical and procedure, the person submits a safety and effectiveness of the device.
Gynecological Devices; Classification premarket notification under section Therefore, on November 2, 2015, FDA
of the Intravaginal Culture System 510(k) of the FD&C Act for a device that issued an order to the requestor
has not previously been classified and, classifying the device into class II. FDA
AGENCY: Food and Drug Administration, within 30 days of receiving an order is codifying the classification of the
HHS. classifying the device into class III device by adding § 884.6165 (21 CFR
ACTION: Final order. under section 513(f)(1) of the FD&CAct, 884.6165).
the person requests a classification
SUMMARY: The Food and Drug under section 513(f)(2). Under the Following the effective date of this
Administration (FDA) is classifying the second procedure, rather than first final classification order, any firm
intravaginal culture system into class II submitting a premarket notification submitting a premarket notification
(special controls). The special controls under section 510(k) of the FD&C Act (510(k)) for an intravaginal culture
that will apply to the device are and then a request for classification system will need to comply with the
identified in this order and will be part under the first procedure, the person special controls named in this final
of the codified language for the determines that there is no legally order. The device is assigned the generic
intravaginal culture system’s marketed device upon which to base a name intravaginal culture system, and it
classification. The Agency is classifying determination of substantial is identified as a prescription device
the device into class II (special controls) equivalence and requests a classification intended for preparing, holding, and
in order to provide a reasonable under section 513(f)(2) of the FD&C Act. transferring human gametes or embryos
assurance of safety and effectiveness of If the person submits a request to during intravaginal in vitro fertilization
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the device. classify the device under this second (IVF) or intravaginal culture procedures.
DATES: This order is effective January 6, procedure, FDA may decline to FDA has identified the following risks
2015. The classification was applicable undertake the classification request if to health associated specifically with
on November 2, 2015. FDA identifies a legally marketed device this type of device, as well as the
FOR FURTHER INFORMATION CONTACT: that could provide a reasonable basis for measures required to mitigate these
Jason Roberts, Center for Devices and review of substantial equivalence with risks in table 1:
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period and subsequent embryo ENVIRONMENTAL PROTECTION FOR FURTHER INFORMATION CONTACT:
extraction; and AGENCY Paula Higbee, Environmental Protection
(v) Ability of the device to permit Agency, Air Planning and Development
40 CFR Part 62 Branch, 11201 Renner Boulevard,
oxygen and carbon dioxide exchange
between the media contained within the [EPA–R07–OAR–2015–0733; FRL–9941–06– Lenexa, Kansas 66219 at 913–551–7028
Region 7] or by email at higbee.paula@epa.gov.
device and the external environment
throughout the vaginal incubation SUPPLEMENTARY INFORMATION:
Approval and Promulgation of State Throughout this document ‘‘we,’’ ‘‘us,’’
period. Plans for Designated Facilities and or ‘‘our’’ refer to EPA. This section
(3) The patient-contacting Pollutants; Nebraska; Sewage Sludge provides additional information by
components of the device must be Incinerators addressing the following:
demonstrated to be biocompatible.
AGENCY: Environmental Protection I. Background
(4) Performance data must Agency (EPA). II. Analysis of State Submittal
demonstrate the sterility of the device ACTION: Direct final rule. III. Statutory and Executive Order Reviews
components intended to be provided I. Background
sterile. SUMMARY: The Environmental Protection
Agency (EPA) is taking direct final The CAA requires that state regulatory
(5) Shelf life testing must demonstrate
action to approve the Clean Air Act agencies implement the emission
that the device maintains its (CAA) section 111(d)/129 negative guidelines and compliance times using
performance characteristics and the declaration for the state of Nebraska, for a state plan developed under sections
packaging of device components labeled existing sewage sludge incinerator (SSI) 111(d) and 129 of the CAA. The general
as sterile maintain integrity and sterility units. This negative declaration certifies provisions for the submittal and
for the duration of the shelf life. that existing SSI units subject to approval of state plans are codified in
(6) Labeling for the device must sections 111(d) and 129 of the CAA do 40 CFR part 60, subpart B and 40 CFR
include: not exist within the jurisdiction of part 62, subpart A. Section 111(d)
Nebraska. EPA is accepting the negative establishes general requirements and
(i) A detailed summary of the clinical
declaration in accordance with the procedures on state plan submittals for
testing, including device effectiveness, requirements of the CAA. the control of designated pollutants.
device-related complications, and
DATES: This direct final rule will be Section 129 requires emission
adverse events;
effective March 7, 2016, without further guidelines to be promulgated for all
(ii) Validated methods and notice, unless EPA receives adverse categories of solid waste incineration
instructions for reprocessing of reusable comment by February 5, 2016. If EPA units, including SSI units. Section 129
components; receives adverse comment, we will mandates that all plan requirements be
(iii) The maximum number of gametes publish a timely withdrawal of the at least as protective and restrictive as
or embryos that can be loaded into the direct final rule in the Federal Register the promulgated emission guidelines.
device; informing the public that the rule will This includes fixed final compliance
not take effect. dates, fixed compliance schedules, and
(iv) A warning that informs users that ADDRESSES: Submit your comments, Title V permitting requirements for all
the embryo development is first identified by Docket ID No. EPA–R07– affected sources. Section 129 also
evaluated following intravaginal OAR–2015–0733, to http:// requires that state plans be submitted to
culture; and www.regulations.gov. Follow the online EPA within one year after EPA’s
(v) A statement that instructs the user instructions for submitting comments. promulgation of the emission guidelines
to use legally marketed assisted Once submitted, comments cannot be and compliance times.
reproductive technology media that edited or removed from Regulations.gov. States have options other than
contain elements to mitigate the The EPA may publish any comment submitting a state plan in order to fulfill
contamination risk (e.g., antibiotics) and received to its public docket. Do not their obligations under CAA sections
to support continued embryonic submit electronically any information 111(d) and 129. If a State does not have
development over the intravaginal you consider to be Confidential any existing Sewage Sludge Incineration
culture period. Business Information (CBI) or other (SSI) units for the relevant emissions
information whose disclosure is guidelines, a letter can be submitted
(7) Patient labeling must be provided restricted by statute. Multimedia certifying that no such units exist
and must include: submissions (audio, video, etc.) must be within the State (i.e., negative
(i) Relevant warnings, precautions, accompanied by a written comment. declaration) in lieu of a state plan. The
and adverse effects and complications; The written comment is considered the negative declaration exempts the State
(ii) Information on how to use the official comment and should include from the requirements of subpart B that
discussion of all points you wish to would otherwise require the submittal
device;
make. The EPA will generally not of a CAA section 111(d)/129 plan.
(iii) The risks and benefits associated consider comments or comment On March 21, 2011 (76 FR 15372), the
with the use of the device; and contents located outside of the primary EPA established emission guidelines
(iv) A summary of the principal submission (i.e. on the web, cloud, or and compliance times for existing SSI
clinical device effectiveness results. other file sharing system). For units. The emission guidelines and
additional submission methods, the full compliance times are codified at 40 CFR
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Dated: December 30, 2015.
EPA public comment policy, 60, Subpart MMMM. In order to fulfill
Leslie Kux, information about CBI or multimedia obligations under CAA sections 111(d)
Associate Commissioner for Policy. submissions, and general guidance on and 129, NDEQ submitted a negative
[FR Doc. 2015–33264 Filed 1–5–16; 8:45 am] making effective comments, please visit declaration letter to EPA on December 6,
BILLING CODE 4164–01–P http://www2.epa.gov/dockets/ 2012. The submittal of this declaration
commenting-epa-dockets. exempts NDEQ from the requirement to
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Document Created: 2016-01-06 04:01:46
Document Modified: 2016-01-06 04:01:46
| 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 January 6, 2015. The classification was applicable on November 2, 2015. | |
| Contact | Jason Roberts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6400, [email protected] | |
| FR Citation | 81 FR 378 |
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