82 FR 60112 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60112-60114 | |
| FR Document | 2017-27277 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Rules and Regulations] [Pages 60112-60114] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27277] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2017-N-6484] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the fetal head elevator 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 fetal head elevator'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 19, 2017. The classification was applicable on July 27, 2017. FOR FURTHER INFORMATION CONTACT: David Birsen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G623, Silver Spring, MD 20993-0002, 240-402-6655, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the fetal head elevator as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to [[Page 60113]] 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 (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ``substantial equivalence''). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On November 20, 2015, Safe Obstetrics Systems, Ltd., submitted a request for De Novo classification of the Fetal Pillow. 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 July 27, 2017, 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 884.4350. We have named the generic type of device fetal head elevator, and it is identified as a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section. 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--Fetal Head Elevator Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility evaluation. Infection.............................. Sterilization validation, Shelf life testing, and Labeling. Fetal injury due to device failure..... Non-clinical performance testing, Shelf life testing, and Labeling. Maternal injury due to device failure.. Non-clinical performance testing, Shelf life testing, and 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) of the FD&C Act. At the time of classification, fetal head elevators are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). III. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information [[Page 60114]] 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 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 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. 884.4350 to subpart E to read as follows: Sec. 884.4350 Fetal head elevator. (a) Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of patient- contacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted. (ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted. (iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted. (5) Labeling must include the following: (i) Contraindication for use in the presence of active genital infection; (ii) Specific instructions regarding the proper placement and use of the device; and (iii) A shelf life. Dated: December 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27277 Filed 12-18-17; 8:45 am] BILLING CODE 4164-01-P
![60112 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
(NPRM) in the Federal Register (82 FR economic impact on a substantial DEPARTMENT OF HEALTH AND
19007) for Docket No. FAA–2017–0209 number of small entities under the HUMAN SERVICES
to remove Class E airspace extending criteria of the Regulatory Flexibility Act.
upward from 700 feet above the surface Food and Drug Administration
at Skyway Estates Airport, Eaton Environmental Review
Rapids, MI. Interested parties were 21 CFR Part 884
The FAA has determined that this
invited to participate in this rulemaking
action qualifies for categorical exclusion [Docket No. FDA–2017–N–6484]
effort by submitting written comments
under the National Environmental
on the proposal to the FAA. No Medical Devices; Obstetrical and
Policy Act in accordance with FAA
comments were received. Gynecological Devices; Classification
Class E airspace designations are Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures,’’ of the Fetal Head Elevator
published in paragraph 6005 of FAA
Order 7400.11B, dated August 3, 2017, paragraph 5–6.5.a. This airspace action AGENCY: Food and Drug Administration,
and effective September 15, 2017, which is not expected to cause any potentially HHS.
is incorporated by reference in 14 CFR significant environmental impacts, and ACTION: Final order.
71.1. The Class E airspace designations no extraordinary circumstances exist
listed in this document will be that warrant preparation of an SUMMARY: The Food and Drug
published subsequently in the Order. environmental assessment. Administration (FDA or we) is
classifying the fetal head elevator into
Availability and Summary of Lists of Subjects in 14 CFR Part 71 class II (special controls). The special
Documents for Incorporation by controls that apply to the device type
Reference Airspace, Incorporation by reference,
are identified in this order and will be
Navigation (air).
This document amends FAA Order part of the codified language for the fetal
7400.11B, Airspace Designations and Adoption of the Amendment head elevator’s classification. We are
Reporting Points, dated August 3, 2017, taking this action because we have
and effective September 15, 2017. FAA In consideration of the foregoing, the determined that classifying the device
Order 7400.11B is publicly available as Federal Aviation Administration into class II (special controls) will
listed in the ADDRESSES section of this amends 14 CFR part 71 as follows: provide a reasonable assurance of safety
document. FAA Order 7400.11B lists and effectiveness of the device. We
Class A, B, C, D, and E airspace areas, PART 71—DESIGNATION OF CLASS A, believe this action will also enhance
air traffic service routes, and reporting B, C, D, AND E AIRSPACE AREAS; AIR patients’ access to beneficial innovative
points. TRAFFIC SERVICE ROUTES; AND devices, in part by reducing regulatory
REPORTING POINTS burdens.
The Rule
DATES: This order is effective December
This amendment to Title 14, Code of ■ 1. The authority citation for part 71 19, 2017. The classification was
Federal Regulations (14 CFR) part 71 continues to read as follows: applicable on July 27, 2017.
removes Class E airspace extending
Authority: 49 U.S.C. 106(f), 106(g); 40103, FOR FURTHER INFORMATION CONTACT:
upward from 700 feet above the surface
at Skyway Estates Airport, Eaton 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, David Birsen, Center for Devices and
Rapids, MI. 1959–1963 Comp., p. 389. Radiological Health, Food and Drug
Airspace reconfiguration is necessary Administration, 10903 New Hampshire
§ 71.1 [Amended] Ave., Bldg. 66, Rm. G623, Silver Spring,
due to the cancellation of the standard
instrument approach procedures at the ■ 2. The incorporation by reference in MD 20993–0002, 240–402–6655,
airport as the airspace is no longer being 14 CFR 71.1 of FAA Order 7400.11B, david.birsen@fda.hhs.gov.
required in compliance with FAA Order Airspace Designations and Reporting SUPPLEMENTARY INFORMATION:
JO 7400.2L, Procedures for Handling Points, dated August 3, 2017, and I. Background
Airspace Matters. effective September 15, 2017, is
amended as follows: Upon request, FDA has classified the
Regulatory Notices and Analyses fetal head elevator as class II (special
The FAA has determined that this Paragraph 6005 Class E Airspace Areas controls), which we have determined
regulation only involves an established Extending Upward From 700 Feet or More will provide a reasonable assurance of
body of technical regulations for which Above the Surface of the Earth. safety and effectiveness. In addition, we
frequent and routine amendments are * * * * * believe this action will enhance
necessary to keep them operationally patients’ access to beneficial innovation,
AGL MI E5 Eaton Rapids, MI [Removed]
current, is non-controversial and in part by reducing regulatory burdens
unlikely to result in adverse or negative Issued in Fort Worth, Texas, on December by placing the device into a lower
comments. It, therefore: (1) Is not a 8, 2017. device class than the automatic class III
‘‘significant regulatory action’’ under Walter Tweedy,
assignment.
Executive Order 12866; (2) is not a The automatic assignment of class III
Acting Manager, Operations Support Group,
‘‘significant rule’’ under DOT occurs by operation of law and without
ATO Central Service Center.
Regulatory Policies and Procedures (44 any action by FDA, regardless of the
[FR Doc. 2017–27205 Filed 12–18–17; 8:45 am]
FR 11034; February 26, 1979); and (3) level of risk posed by the new device.
sradovich on DSK3GMQ082PROD with RULES
does not warrant preparation of a BILLING CODE 4910–13–P Any device that was not in commercial
regulatory evaluation as the anticipated distribution before May 28, 1976, is
impact is so minimal. Since this is a automatically classified as, and remains
routine matter that only affects air traffic within, class III and requires premarket
procedures and air navigation, it is approval unless and until FDA takes an
certified that this rule, when action to classify or reclassify the device
promulgated, does not have a significant (see 21 U.S.C. 360c(f)(1)). We refer to
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![60114 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Rules and Regulations
found in other FDA regulations. These (i) Reliability testing of device I. Background
collections of information are subject to deployment and retrieval under relevant Upon request, FDA has classified the
review by the Office of Management and use conditions must be conducted. tear electrostimulation device as class II
Budget (OMB) under the Paperwork (ii) Testing of the maximum force (special controls), which we have
Reduction Act of 1995 (44 U.S.C. 3501– applied to the fetal head in an anatomic determined will provide a reasonable
3520). The collections of information in model must be conducted. assurance of safety and effectiveness. In
the guidance document ‘‘De Novo (iii) Testing of uniform application of
addition, we believe this action will
Classification Process (Evaluation of the elevator mechanism on the fetal
enhance patients’ access to beneficial
Automatic Class III Designation)’’ have head must be conducted.
innovation, in part by reducing
been approved under OMB control (5) Labeling must include the
regulatory burdens by placing the
number 0910–0844; the collections of following:
device into a lower device class than the
information in 21 CFR part 814, (i) Contraindication for use in the
automatic class III assignment.
subparts A through E, regarding presence of active genital infection;
The automatic assignment of class III
premarket approval, have been (ii) Specific instructions regarding the
occurs by operation of law and without
approved under OMB control number proper placement and use of the device;
any action by FDA, regardless of the
0910–0231; the collections of and
(iii) A shelf life. level of risk posed by the new device.
information in part 807, subpart E, Any device that was not in commercial
regarding premarket notification Dated: December 14, 2017. distribution before May 28, 1976, is
submissions, have been approved under Leslie Kux, automatically classified as, and remains
OMB control number 0910–0120; and Associate Commissioner for Policy. within, class III and requires premarket
the collections of information in 21 CFR [FR Doc. 2017–27277 Filed 12–18–17; 8:45 am] approval unless and until FDA takes an
part 801, regarding labeling, have been BILLING CODE 4164–01–P action to classify or reclassify the device
approved under OMB control number (see 21 U.S.C. 360c(f)(1)). We refer to
0910–0485. these devices as ‘‘postamendments
List of Subjects in 21 CFR Part 884 DEPARTMENT OF HEALTH AND devices’’ because they were not in
HUMAN SERVICES commercial distribution prior to the
Medical devices.
date of enactment of the Medical Device
Therefore, under the Federal Food, Food and Drug Administration Amendments of 1976, which amended
Drug, and Cosmetic Act and under the Federal Food, Drug, and Cosmetic
authority delegated to the Commissioner 21 CFR Part 886 Act (FD&C Act).
of Food and Drugs, 21 CFR part 884 is FDA may take a variety of actions in
[Docket No. FDA–2017–N–6597]
amended as follows: appropriate circumstances to classify or
PART 884—OBSTETRICAL AND Medical Devices; Ophthalmic Devices; reclassify a device into class I or II. We
GYNECOLOGICAL DEVICES Classification of the Tear may issue an order finding a new device
Electrostimulation Device to be substantially equivalent under
■ 1. The authority citation for part 884 section 513(i) of the FD&C Act (21
AGENCY: Food and Drug Administration, U.S.C. 360c(i)) to a predicate device that
continues to read as follows: HHS. does not require premarket approval.
Authority: 21 U.S.C. 351, 360, 360c, 360e, ACTION: Final order.
360j, 360l, 371. We determine whether a new device is
SUMMARY: The Food and Drug substantially equivalent to a predicate
■ 2. Add § 884.4350 to subpart E to read by means of the procedures for
as follows: Administration (FDA or we) is
classifying the tear electrostimulation premarket notification under section
§ 884.4350 Fetal head elevator. device into class II (special controls). 510(k) of the FD&C Act and part 807 (21
(a) Identification. A fetal head The special controls that apply to the U.S.C. 360(k) and 21 CFR part 807,
elevator is a prescription device device type are identified in this order respectively).
consisting of a mechanism that elevates FDA may also classify a device
and will be part of the codified language
the fetal head to facilitate delivery through ‘‘De Novo’’ classification, a
for the tear electrostimulation device’s
during a Caesarean section. common name for the process
classification. We are taking this action
(b) Classification. Class II (special authorized under section 513(f)(2) of the
because we have determined that
controls). The special controls for this FD&C Act. Section 207 of the Food and
classifying the device into class II
device are: Drug Administration Modernization Act
(special controls) will provide a
(1) The patient-contacting of 1997 established the first procedure
reasonable assurance of safety and
components of the device must be for De Novo classification (Pub. L. 105–
effectiveness of the device. We believe
demonstrated to be biocompatible. 115). Section 607 of the Food and Drug
this action will also enhance patients’
(2) Performance data must Administration Safety and Innovation
access to beneficial innovative devices,
demonstrate the sterility of patient- Act modified the De Novo application
in part by reducing regulatory burdens.
contacting components of the device. process by adding a second procedure
DATES: This order is effective December (Pub. L. 112–144). A device sponsor
(3) Performance data must support the
shelf life of the device by demonstrating 19, 2017. The classification was may utilize either procedure for De
continued sterility, package integrity, applicable on April 24, 2017. Novo classification.
and device functionality over the FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person
sradovich on DSK3GMQ082PROD with RULES
identified shelf life. Scott Steffen, Center for Devices and submits a 510(k) for a device that has
(4) Non-clinical performance data Radiological Health, Food and Drug not previously been classified. After
must demonstrate that the device Administration, 10903 New Hampshire receiving an order from FDA classifying
performs as intended under anticipated Ave., Bldg. 66, Rm. 2574, Silver Spring, the device into class III under section
conditions of use. The following MD 20993–0002, 240–402–8795, 513(f)(1) of the FD&C Act, the person
performance characteristics must be Scott.Steffen@fda.hhs.gov. then requests a classification under
tested: SUPPLEMENTARY INFORMATION: section 513(f)(2).
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Document Created: 2017-12-19 01:31:31
Document Modified: 2017-12-19 01:31:31
| 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 19, 2017. The classification was applicable on July 27, 2017. | |
| Contact | David Birsen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G623, Silver Spring, MD 20993-0002, 240-402-6655, [email protected] | |
| FR Citation | 82 FR 60112 |
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