82 FR 35069 - Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 144 (July 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35069-35071 | |
| FR Document | 2017-15895 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Rules and Regulations] [Pages 35069-35071] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15895] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-1608] Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement device 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 cranial motion measurement device'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 July 28, 2017. The classification was applicable on August 1, 2016. FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2630, Silver Spring, MD 20993-0002, 301-796-2795, [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 [[Page 35070]] 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, also known as De Novo classification, 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) of the FD&C Act. 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), the person requests a classification under section 513(f)(2) of the FD&C Act. 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On December 23, 2014, Jan Medical, Inc., submitted a request for classification of the BrainPulse, Model 1100, under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request 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 August 1, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.1630. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a cranial motion measurement device will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome 510(k) pathway, when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name cranial motion measurement device, and it is identified as a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes. 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--Cranial Motion Measurement Device Risks to Health and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility evaluation. Labeling. Equipment malfunction leading to injury Electrical safety, thermal, and to user or patient. mechanical testing. Electromagnetic compatibility testing. Labeling. Inaccurate measurement................. Clinical performance testing. Hardware and software verification, validation, and hazard analysis. Electromagnetic compatibility testing. Labeling. Use error.............................. Hardware and software verification, validation, and hazard analysis. Labeling. ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. Cranial motion measurement devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (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 [[Page 35071]] effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the cranial motion measurement device prior to marketing. II. 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. 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. List of Subjects in 21 CFR Part 882 Medical devices; Neurological devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: PART 882--NEUROLOGICAL DEVICES 0 1. The authority citation for part 882 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 882.1630 to subpart B to read as follows: Sec. 882.1630 Cranial motion measurement device. (a) Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes. (b) Classification. Class II (special controls). The special controls for this device are: (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed. (ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC). (4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment. (5) The labeling must include: (i) The intended use population and the intended use environment. (ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability. (iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement. Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-15895 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations 35069
Section 510(m) of the FD&C Act § 876.5981 Oral removable palatal space procedures for determining a patient’s
provides that FDA may exempt a class occupying device for weight management oral health status, instructions for
II device from the premarket notification and/or weight loss. making the palatal mold, and
requirements under section 510(k), if (a) Identification. An oral removable assessment of issues with the device
FDA determines that premarket palatal space occupying device for that may require service by the
notification is not necessary to provide weight management and/or weight loss manufacturer.
reasonable assurance of the safety and is a prescription device that is worn
Dated: July 24, 2017.
effectiveness of the device. For this type during meals to limit bite size, thereby
reducing the amount of food that is Leslie Kux,
of device, FDA believes premarket
consumed. The device may contain Associate Commissioner for Policy.
notification is not necessary to provide
reasonable assurance of the safety and recording sensors for monitoring patient [FR Doc. 2017–15894 Filed 7–27–17; 8:45 am]
effectiveness of the device type and, use. This classification does not include BILLING CODE 4164–01–P
therefore, is planning to exempt the devices that are intended to treat any
device from the premarket notification dental diseases or conditions
requirements under section 510(m) of (b) Classification. Class II (special DEPARTMENT OF HEALTH AND
the FD&C Act. Once finalized, persons controls). The special controls for this HUMAN SERVICES
who intend to market this device type device are:
(1) The patient-contacting Food and Drug Administration
need not submit a 510(k) premarket
notification containing information on components of the device must be
demonstrated to be biocompatible for its 21 CFR Part 882
the oral removable palatal space
occupying device for weight intended use. [Docket No. FDA–2017–N–1608]
management and/or weight loss prior to (2) Non-clinical performance testing
marketing the device. must demonstrate that the device Medical Devices; Neurological
performs as intended under anticipated Devices; Classification of Cranial
II. Analysis of Environmental Impact conditions for use, as follows: Motion Measurement Device
The Agency has determined under 21 (i) Mechanical testing must
demonstrate that the device performs as AGENCY: Food and Drug Administration,
CFR 25.34(b) that this action is of a type
intended for the labeled use life and HHS.
that does not individually or
cumulatively have a significant effect on does not create forces that result in ACTION: Final order.
the human environment. Therefore, movement of teeth and damage to teeth. SUMMARY: The Food and Drug
neither an environmental assessment (ii) Electrical safety and
Administration (FDA or Agency) is
nor an environmental impact statement electromagnetic compatibility testing
classifying the cranial motion
is required. must demonstrate that the device
measurement device into class II
performs as intended.
III. Paperwork Reduction Act of 1995 (iii) Software verification and (special controls). The special controls
This final order establishes special validation must demonstrate that the that will apply to the device are
controls that refer to previously device performs as intended. identified in this order and will be part
approved collections of information (iv) Battery testing must demonstrate of the codified language for the cranial
found in other FDA regulations. These that the device battery performs as motion measurement device’s
collections of information are subject to intended. classification. The Agency is classifying
review by the Office of Management and (3) Clinical performance testing must the device into class II (special controls)
Budget (OMB) under the Paperwork demonstrate the device performs as in order to provide a reasonable
Reduction Act of 1995 (44 U.S.C. 3501– intended and must include an assurance of safety and effectiveness of
3520). The collections of information in evaluation for choking. the device.
part 807, subpart E, regarding premarket (4) Device labeling must address the DATES: This order is effective July 28,
notification submissions have been following: 2017. The classification was applicable
approved under OMB control number (i) Patient labeling must state: on August 1, 2016.
0910–0120, and the collections of (A) The clinical benefit of weight FOR FURTHER INFORMATION CONTACT: Jay
information in 21 CFR part 801 management and/or weight loss as Gupta, Center for Devices and
regarding labeling have been approved assessed by using percent total body Radiological Health, Food and Drug
under OMB control number 0910–0485. weight loss; Administration, 10903 New Hampshire
(B) Treatment must be offered in Ave., Bldg. 66, Rm. 2630, Silver Spring,
List of Subjects in 21 CFR Part 876 combination with a behavioral MD 20993–0002, 301–796–2795,
Medical devices. modification program; jay.gupta@fda.hhs.gov.
(C) Instructions on how to use the
Therefore, under the Federal Food, SUPPLEMENTARY INFORMATION:
device as intended; and
Drug, and Cosmetic Act and under
(D) The use life of the device. I. Background
authority delegated to the Commissioner (ii) Physician labeling must state:
of Food and Drugs, 21 CFR part 876 is (A) The clinical benefit of weight In accordance with section 513(f)(1) of
amended as follows: management and/or weight loss as the Federal Food, Drug, and Cosmetic
assessed by using percent total body Act (the FD&C Act) (21 U.S.C.
PART 876—GASTROENTEROLOGY- 360c(f)(1)), devices that were not in
weight loss;
asabaliauskas on DSKBBXCHB2PROD with RULES
UROLOGY DEVICES (B) Treatment must be offered in commercial distribution before May 28,
combination with a behavioral 1976 (the date of enactment of the
■ 1. The authority citation for part 876
modification program; Medical Device Amendments of 1976),
continues to read as follows:
(C) Instructions on how to use the generally referred to as postamendments
Authority: 21 U.S.C. 351, 360, 360c, 360e, device as intended; and devices, are classified automatically by
360j, 360l, 371. (D) The use life of the device. statute into class III without any FDA
■ 2. Add § 876.5981 to subpart F to read (5) Training must be provided to rulemaking process. These devices
as follows: health professionals that includes remain in class III and require
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![Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations 35071
effectiveness of the device. For this type (b) Classification. Class II (special classifying the closed loop
of device, FDA believes premarket controls). The special controls for this hysteroscopic insufflator with cutter-
notification is not necessary to provide device are: coagulator into class II (special
reasonable assurance of the safety and (1) The technical parameters of the controls). The special controls that will
effectiveness of the device type and, device, hardware and software, must be apply to the device are identified in this
therefore, is planning to exempt the fully characterized and include the order, and will be part of the codified
device from the premarket notification following information: language for the closed loop
requirements under section 510(m) of (i) Hardware specifications must be hysteroscopic insufflator with cutter-
the FD&C Act. Once finalized, persons provided. Additionally, verification and coagulator classification. The Agency is
who intend to market this device type validation testing as well as a hazard classifying the device into class II
need not submit a 510(k) premarket analysis must be performed. (special controls) in order to provide a
notification containing information on (ii) Software must be described in reasonable assurance of safety and
the cranial motion measurement device detail in the Software Requirements effectiveness of the device.
prior to marketing. Specification (SRS) and Software Design DATES: This order is effective July 28,
Specification (SDS). Additionally, 2017. The classification was applicable
II. Analysis of Environmental Impact software verification and validation on March 28, 2014.
The Agency has determined under 21 testing as well as a hazard analysis must
FOR FURTHER INFORMATION CONTACT:
CFR 25.34(b) that this action is of a type be performed.
(2) The device parts that contact the Veronica Price, Center for Devices and
that does not individually or Radiological Health, Food and Drug
cumulatively have a significant effect on patient must be demonstrated to be
biocompatible. Administration, 10903 New Hampshire
the human environment. Therefore, Ave., Bldg. 66, Rm. G116, Silver Spring,
neither an environmental assessment (3) The device must be designed and
tested for electrical, thermal, and MD 20993–0002, 301–796–6538.
nor an environmental impact statement
mechanical safety, and electromagnetic SUPPLEMENTARY INFORMATION:
is required.
compatibility (EMC). I. Background
III. Paperwork Reduction Act of 1995 (4) Clinical performance testing must
This final order establishes special demonstrate the accuracy, precision, In accordance with section 513(f)(1) of
controls that refer to previously stability, and repeatability of measuring the Federal Food, Drug, and Cosmetic
approved collections of information cranial motion per the intended use in Act (the FD&C Act) (21 U.S.C.
found in other FDA regulations. These the intended use environment. 360c(f)(1)), devices that were not in
collections of information are subject to (5) The labeling must include: commercial distribution before May 28,
review by the Office of Management and (i) The intended use population and 1976 (the date of enactment of the
Budget (OMB) under the Paperwork the intended use environment. Medical Device Amendments of 1976),
Reduction Act of 1995 (44 U.S.C. 3501– (ii) Instructions for technicians to generally referred to as postamendments
3520). The collections of information in convey to patients regarding the devices, are classified automatically by
part 807, subpart E, regarding premarket collection of cranial acceleration data to statute into class III without any FDA
notification submissions have been ensure device measurement accuracy, rulemaking process. These devices
approved under OMB control number precision, stability, and repeatability. remain in class III and require
0910–0120, and the collections of (iii) Information allowing clinicians to premarket approval, unless and until
information in 21 CFR part 801 understand potential sources of the device is classified or reclassified
regarding labeling have been approved variability in the measurement to help into class I or II, or FDA issues an order
under OMB control number 0910–0485. recognize and identify changes in the finding the device to be substantially
measurement. equivalent, in accordance with section
List of Subjects in 21 CFR Part 882 Dated: July 24, 2017. 513(i) of the FD&C Act, to a predicate
Medical devices; Neurological Leslie Kux,
device that does not require premarket
devices. approval. The Agency determines
Associate Commissioner for Policy.
Therefore, under the Federal Food, whether new devices are substantially
[FR Doc. 2017–15895 Filed 7–27–17; 8:45 am]
Drug, and Cosmetic Act and under equivalent to predicate devices by
BILLING CODE 4164–01–P means of premarket notification
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is procedures in section 510(k) of the
amended as follows: FD&C Act (21 U.S.C. 360(k)) and part
DEPARTMENT OF HEALTH AND 807 (21 CFR part 807) of the regulations.
HUMAN SERVICES Section 513(f)(2) of the FD&C Act,
PART 882—NEUROLOGICAL DEVICES
Food and Drug Administration also known as De Novo classification, as
■ 1. The authority citation for part 882 amended by section 607 of the Food and
continues to read as follows: 21 CFR Part 884 Drug Administration Safety and
Authority: 21 U.S.C. 351, 360, 360c, 360e, Innovation Act (Pub. L. 112–144),
360j, 360l, 371. [Docket No. FDA–2017–N–1914] provides two procedures by which a
■ 2. Add § 882.1630 to subpart B to read person may request FDA to classify a
Medical Devices; Obstetrical and device under the criteria set forth in
as follows: Gynecological Devices; Classification section 513(a)(1). Under the first
asabaliauskas on DSKBBXCHB2PROD with RULES
§ 882.1630 Cranial motion measurement of the Closed Loop Hysteroscopic procedure, the person submits a
device. Insufflator With Cutter-Coagulator premarket notification under section
(a) Identification. A cranial motion AGENCY: Food and Drug Administration, 510(k) of the FD&C Act for a device that
measurement device is a prescription HHS. has not previously been classified and,
device that utilizes accelerometers to ACTION: Final order. within 30 days of receiving an order
measure the motion or acceleration of classifying the device into class III
the skull. These measurements are not SUMMARY: The Food and Drug under section 513(f)(1) of the FD&C Act,
to be used for diagnostic purposes. Administration (FDA, Agency, or we) is the person requests a classification
VerDate Sep<11>2014 17:01 Jul 27, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\28JYR1.SGM 28JYR1](https://thefederalregister.org/doc/82_FR_35213/page/3.svg)
Document Created: 2017-07-28 03:09:44
Document Modified: 2017-07-28 03:09:44
| 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 July 28, 2017. The classification was applicable on August 1, 2016. | |
| Contact | Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2630, Silver Spring, MD 20993-0002, 301-796-2795, [email protected] | |
| FR Citation | 82 FR 35069 |
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