82 FR 50080 - Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50080-50082 | |
| FR Document | 2017-23516 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Rules and Regulations] [Pages 50080-50082] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23516] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-5934] Medical Devices; Neurological Devices; Classification of the Non- Electroencephalogram Physiological Signal Based Seizure Monitoring System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system 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 non-EEG physiological signal based seizure monitoring system's classification. We [[Page 50081]] 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 October 30, 2017. The classification was applicable on February 16, 2017. FOR FURTHER INFORMATION CONTACT: Xiaorui Tang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2609, Silver Spring, MD 20993-0002, 301-796-6500, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the non-EEG physiological signal based seizure monitoring system 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 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 (the 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 10, 2014, Brain Sentinel, Inc., submitted a request for De Novo classification of the Brain Sentinel Monitoring and Alerting System. 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on February 16, 2017, 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 882.1580. We have named the generic type of device non-EEG physiological signal based seizure monitoring system, and it is identified as a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure. 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--Non-EEG Physiological Signal Based Seizure Monitoring System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility evaluation. Equipment malfunction leading to injury Electrical safety, thermal, and to users (shock, burn). mechanical testing; Electromagnetic compatibility testing; and Labeling. Interference with or from other Electromagnetic compatibility electrical devices. testing. [[Page 50082]] Incorrect alerts, including: ...............................Missing a seizure--device Clinical performance testing; fails to identify physiological Non-clinical performance signal that is associated with a testing; seizure; or. Software verification, False alarm--device validation, and hazard mistakenly identifies a analysis; physiological signal as being Labeling; and associated with a seizure. Training. ------------------------------------------------------------------------ FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the 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, non-EEG physiological signal based seizure monitoring systems 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. III. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 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. 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. 882.1580 to subpart B to read as follows: Sec. 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system. (a) Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure. (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. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The patient-contacting components of the device 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 ability of the device to function as an assessment aid for monitoring for seizure- related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate. (5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data. (6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information: (i) A detailed summary of the clinical performance testing, including any adverse events and complications. (ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data. (iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device. Dated: October 24, 2017. Lauren Silvis, Chief of Staff. [FR Doc. 2017-23516 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
![50080 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
of TREC levels and include samples professional standards of practice, whether FDA planned to exempt the
within the measuring range, samples including confirmation by alternative device from premarket notification
above and below the measuring range, methods and clinical evaluation, as requirements under section 510(k) of the
and samples very near above and below appropriate.’’; FD&C Act.
the cutoff value. Multiple punches must (iii) A description of the performance In the Federal Register of July 28,
be obtained from each card for studies listed in paragraph (b)(1)(iii) and 2017, (82 FR 35067), the following
demonstration of homogeneity of the a summary of the results; and correction is made: On page 35069, in
analyte across the dried blood spot. (iv) A description of the filter paper the first column, the first paragraph is
Comparability of the test performance specifications required for the test. corrected as follows:
for each filter paper must be Dated: October 24, 2017.
‘‘Section 510(m) of the FD&C Act
demonstrated. Stability and storage of provides that FDA may exempt a class
Anna K. Abram,
TREC DNA on each blood spot card II device from the premarket notification
Deputy Commissioner for Policy, Planning, requirements under section 510(k), if
must be demonstrated. Results of the Legislation, and Analysis.
lot-to-lot study must be summarized FDA determines that premarket
[FR Doc. 2017–23496 Filed 10–27–17; 8:45 am] notification is not necessary to provide
providing the mean, standard deviation,
and percentage coefficient of variation BILLING CODE 4164–01–P reasonable assurance of the safety and
in a tabular format. Data must be effectiveness of the device. For this type
calculated for within-run, between-run, of device, FDA has determined that
DEPARTMENT OF HEALTH AND premarket notification is necessary to
within-lot, and between-lot. Data
HUMAN SERVICES provide reasonable assurance of the
demonstrating the concordance between
results across different filter papers safety and effectiveness of the device.
Food and Drug Administration
must be provided. Study acceptance Therefore, this device type is not
criteria must be provided and followed; exempt from premarket notification
21 CFR Part 876
and requirements. Persons who intend to
(I) If applicable, a thermocycler [Docket No. FDA–2017–N–1609] market this type of device must submit
reproducibility study must be to FDA a premarket notification, prior to
performed using thermocyclers from Medical Devices; Gastroenterology- marketing the device, which contains
three independent thermocyler Urology Devices; Classification of the information about the oral removable
manufacturers. The sample panel must Oral Removable Palatal Space palatal space occupying device for
consist of specimens with a range of Occupying Device for Weight weight management and/or weight loss
TREC levels and must include samples Management and/or Weight Loss they intend to market.’’
within the measuring range, samples AGENCY: Food and Drug Administration, Dated: October 24, 2017.
above and below the measuring range, HHS. Anna K. Abram,
and samples very near above and below
ACTION: Final order; correction. Deputy Commissioner for Policy, Planning,
the cutoff value. The study must be Legislation, and Analysis.
done using three filter paper lots and SUMMARY: The Food and Drug [FR Doc. 2017–23490 Filed 10–27–17; 8:45 am]
conducted over five nonconsecutive Administration (FDA) is correcting a BILLING CODE 4164–01–P
days. Results of the thermocycler final order entitled ‘‘Medical Devices;
reproducibility study must be Gastroenterology-Urology Devices;
summarized providing the mean, Classification of the Oral Removable DEPARTMENT OF HEALTH AND
standard deviation, and percentage Palatal Space Occupying Device for HUMAN SERVICES
coefficient of variance in a tabular Weight Management and/or Weight
format. Data must be calculated for the Loss’’ that appeared in the Federal Food and Drug Administration
within-run, between-run, within-lot, Register of July 28, 2017. The final order
between-lot, and between thermocycler was published with an incorrect 21 CFR Part 882
manufacturer study results. Study statement in the preamble about
acceptance criteria must be provided [Docket No. FDA–2017–N–5934]
whether FDA planned to exempt the
and followed. device from premarket notification Medical Devices; Neurological
(iv) Identification of risk mitigation requirements. This document corrects Devices; Classification of the Non-
elements used by your device, including that error. Electroencephalogram Physiological
a description of all additional
DATES: Effective October 30, 2017 Signal Based Seizure Monitoring
procedures, methods, and practices
FOR FURTHER INFORMATION CONTACT: System
incorporated into the directions for use
that mitigate risks associated with Mark Antonino, Center for Devices and AGENCY: Food and Drug Administration,
testing. Radiological Health, Food and Drug HHS.
(2) Your § 809.10 compliant labeling Administration, 10903 New Hampshire
ACTION: Final order.
must include: Ave., Bldg. 66, Rm. G208, Silver Spring,
(i) A warning statement that reads MD 20993–0002, 240–402–9980, SUMMARY: The Food and Drug
‘‘This test is not intended for diagnostic mark.antonino@fda.hhs.gov. Administration (FDA or we) is
use, preimplantation or prenatal testing, SUPPLEMENTARY INFORMATION: In the classifying the non-
or for screening of SCID-like syndromes, Federal Register of July 28, 2017 (82 FR electroencephalogram (non-EEG)
such as DiGeorge syndrome or Omenn 35067), FDA published the final order physiological signal based seizure
nlaroche on DSK9F9SC42PROD with RULES
syndrome. It is also not intended to ‘‘Medical Devices; Gastroenterology- monitoring system into class II (special
screen for less acute SCID syndromes, Urology Devices; Classification of the controls). The special controls that
such as leaky SCID or variant SCID.’’; Oral Removable Palatal Space apply to the device type are identified
(ii) A warning statement that reads Occupying Device for Weight in this order and will be part of the
‘‘Test results are intended to be used in Management and/or Weight Loss.’’ The codified language for the non-EEG
conjunction with other clinical and final order published with an incorrect physiological signal based seizure
diagnostic findings, consistent with statement in the preamble about monitoring system’s classification. We
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![50082 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
TABLE 1—NON-EEG PHYSIOLOGICAL SIGNAL BASED SEIZURE MONITORING SYSTEM RISKS AND MITIGATION MEASURES—
Continued
Identified risks Mitigation measures
Incorrect alerts, including:
• Missing a seizure—device fails to identify physiological signal Clinical performance testing;
that is associated with a seizure; or. Non-clinical performance testing;
• False alarm—device mistakenly identifies a physiological signal Software verification, validation, and hazard analysis;
as being associated with a seizure. Labeling; and
Training.
FDA has determined that special Therefore, under the Federal Food, monitoring for seizure-related activity in
controls, in combination with the Drug, and Cosmetic Act and under the intended population and for the
general controls, address these risks to authority delegated to the Commissioner intended use setting. Performance
health and provide reasonable assurance of Food and Drugs, 21 CFR part 882 is measurements must include positive
of the safety and effectiveness. In order amended as follows: percent agreement and false alarm rate.
for a device to fall within this (5) Training must be provided for
classification, and thus avoid automatic PART 882—NEUROLOGICAL DEVICES intended users that includes
classification in class III, it would have information regarding the proper use of
to comply with the special controls ■ 1. The authority citation for part 882 the device and factors that may affect
named in this final order. The necessary continues to read as follows: the collection of the physiologic data.
special controls appear in the regulation Authority: 21 U.S.C. 351, 360, 360c, 360e, (6) The labeling must include health
codified by this order. This device is 360j, 360l, 371. care professional labeling and patient-
subject to premarket notification ■ 2. Add § 882.1580 to subpart B to read caregiver labeling. The health care
requirements under section 510(k) of the as follows: professional and the patient-caregiver
FD&C Act. labeling must include the following
At the time of classification, non-EEG § 882.1580 Non-electroencephalogram information:
physiological signal based seizure (EEG) physiological signal based seizure (i) A detailed summary of the clinical
monitoring systems are for prescription monitoring system. performance testing, including any
use only. Prescription devices are (a) Identification. A non- adverse events and complications.
exempt from the requirement for electroencephalogram (non-EEG) (ii) Any instructions technicians and
adequate directions for use for the physiological signal based seizure clinicians should convey to patients and
layperson under section 502(f)(1) of the monitoring system is a noninvasive caregivers regarding the proper use of
FD&C Act (21 U.S.C. 352(f)(1)) and 21 prescription device that collects the device and factors that may affect
CFR 801.5, as long as the conditions of physiological signals other than EEG to the collection of the physiologic data.
21 CFR 801.109 are met. identify physiological signals that may (iii) Instructions to technicians and
be associated with a seizure. clinicians regarding how to set the
III. Analysis of Environmental Impact (b) Classification. Class II (special device threshold to achieve the
The Agency has determined under 21 controls). The special controls for this intended performance of the device.
CFR 25.34(b) that this action is of a type device are: Dated: October 24, 2017.
that does not individually or (1) The technical parameters of the
Lauren Silvis,
cumulatively have a significant effect on device, hardware and software, must be
Chief of Staff.
the human environment. Therefore, fully characterized and include the
following information: [FR Doc. 2017–23516 Filed 10–27–17; 8:45 am]
neither an environmental assessment
nor an environmental impact statement (i) Hardware specifications must be BILLING CODE 4164–01–P
is required. provided. Appropriate verification,
validation, and hazard analysis must be
IV. Paperwork Reduction Act of 1995 performed. DEPARTMENT OF HOMELAND
This final order establishes special (ii) Software, including any SECURITY
controls that refer to previously proprietary algorithm(s) used by the
approved collections of information device to achieve its intended use, must Coast Guard
found in other FDA regulations. These be described in detail in the Software
collections of information are subject to Requirements Specification (SRS) and 33 CFR Part 117
review by the Office of Management and Software Design Specification (SDS). [Docket No. USCG 2017–0162]
Budget (OMB) under the Paperwork Appropriate software verification,
Reduction Act of 1995 (44 U.S.C. 3501– validation, and hazard analysis must be RIN 1625–AA09
3520). The collections of information in performed. Drawbridge Operation Regulation;
part 807, subpart E, regarding premarket (2) The patient-contacting
Nanticoke River, Seaford, DE
notification submissions have been components of the device must be
approved under OMB control number demonstrated to be biocompatible. AGENCY: Coast Guard, DHS.
nlaroche on DSK9F9SC42PROD with RULES
0910–0120, and the collections of (3) The device must be designed and ACTION: Final rule.
information in 21 CFR part 801, tested for electrical, thermal, and
regarding labeling have been approved mechanical safety and electromagnetic SUMMARY: The Coast Guard is modifying
under OMB control number 0910–0485. compatibility (EMC). the operating schedule that governs the
(4) Clinical performance testing must SR 13 Bridge across the Nanticoke
List of Subjects in 21 CFR Part 882 demonstrate the ability of the device to River, mile 39.6, in Seaford, Delaware
Medical devices. function as an assessment aid for (DE). This modification will require the
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Document Created: 2017-10-28 00:28:41
Document Modified: 2017-10-28 00:28:41
| 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 30, 2017. The classification was applicable on February 16, 2017. | |
| Contact | Xiaorui Tang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2609, Silver Spring, MD 20993-0002, 301-796-6500, [email protected] | |
| FR Citation | 82 FR 50080 |
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