9228 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Rules and Regulations 
(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 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; the collections of information in part 820, regarding quality system regulation, have been approved under OMB control number 0910–0073; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910–0485. 
List of Subjects in 21 CFR Part 866 
Biologics, Laboratories, 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 866 is amended as follows: 
PART 866—IMMUNOLOGY AND 
MICROBIOLOGY DEVICES 
■1. The authority citation for part 866 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 866.3985 to subpart D to read 
as follows: 
§ 866.3985 Device to detect and identify 
microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. 
(a) Identification. A device to detect 
and identify microorganisms and 
associated resistance marker nucleic acids directly from respiratory specimens is an in vitro diagnostic device intended for the detection and identification of microorganisms and associated resistance markers in respiratory specimens collected from patients with signs or symptoms of respiratory infection. The device is intended to aid in the diagnosis of respiratory infection in conjunction with clinical signs and symptoms and other laboratory findings. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist other than those detected by the device. (b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) The intended use for the 21 CFR 
809.10 labeling must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. 
(2) The 21 CFR 809.10(b) labeling 
must include: 
(i) A detailed device description, 
including all device components, control elements incorporated into the test procedure, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology, including all pre- analytical methods for processing of specimens. 
(ii) Performance characteristics from 
analytical studies, including, but not limited to, limit of detection, inclusivity, reproducibility, cross reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, and linearity, as applicable. 
(iii) A limiting statement that the 
device is intended to be used in conjunction with clinical history, signs and symptoms, and results of other diagnostic tests, including culture and antimicrobial susceptibility testing. 
(iv) A detailed explanation of the 
interpretation of test results for clinical specimens and acceptance criteria for any quality control testing. 
(v) A limiting statement that negative 
results for microorganisms do not preclude the possibility of infection, and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. 
(vi) If applicable, a limiting statement 
that detected microorganisms may not be the cause of lower respiratory tract infection and may be indicative of colonizing or normal respiratory flora. 
(vii) If applicable, a limiting statement 
that detection of resistance markers cannot be definitively linked to specific microorganisms and that the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora. 
(viii) If applicable, a limiting 
statement that detection of antibiotic resistance markers may not correlate with phenotypic gene expression. 
(3) The 21 CFR 809.10(b) labeling and 
any test report generated by the device must include a limiting statement that negative results for resistance markers do not indicate susceptibility of detected microorganisms. (4) Design verification and validation 
must include: 
(i) Performance characteristics from 
clinical studies that include prospective (sequential) samples and, if appropriate, additional characterized samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from an FDA accepted reference method and/or FDA accepted comparator method, as appropriate. Results from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan, if applicable), clinical study report, and results of all statistical analyses. 
(ii) A detailed device description 
including the following: 
(A) Thorough description of the assay 
methodology including, but not limited to, primer/probe sequences, primer/ probe design, and rationale for target sequence selection, as applicable. 
(B) Algorithm used to generate a final 
result from raw data (e.g., how raw 
signals are converted into a reported result). 
(iii) A detailed description of device 
software, including, but not limited to, validation activities and outcomes. 
(iv) As part of the risk management 
activities, an appropriate end user device training program must be offered as an effort to mitigate the risk of failure from user error. 
Dated: March 8, 2019. 
Lowell J. Schiller, 
Acting Associate Commissioner for Policy. 
[FR Doc. 2019–04719 Filed 3–13–19; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 882 
[Docket No. FDA–2019–N–0396] 
Medical Devices; Neurological 
Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions into class II (special controls). The 
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special controls that apply to the device 
type are identified in this order and will be part of the codified language for the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions’ 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 March 14, 
2019. The classification was applicable on August 16, 2018. 
FOR FURTHER INFORMATION CONTACT : John 
Doucet, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993–0002, 301–796–6474, John.Doucet@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions 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 (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 to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) (21 U.S.C. 360(k)) of the FD&C Act and part 807 (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 is required to 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 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 510(k) process, when necessary, to market their device. 
II. De Novo Classification 
On September 29, 2017, Brainsway 
Ltd. submitted a request for De Novo 
classification of the Brainsway Deep Transcranial Magnetic Stimulation 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 the general controls, will provide reasonable assurance of the safety and effectiveness of the device. 
Therefore, on August 16, 2018, 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 882.5802. We have named the generic type of device transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions, and it is identified as a prescription, non- implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive 
transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808. 
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. 
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TABLE 1—T RANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR NEUROLOGICAL AND PSYCHIATRIC DISORDERS AND  
CONDITIONS RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Seizure ...................................................................................................... Non-clinical performance testing, and Labeling. 
Thermal injury ........................................................................................... Non-clinical performan ce testing; Thermal safety testing; Electrical 
safety testing; Software verification, validation, and hazard analysis; 
and Labeling. 
Hearing loss .............................................................................................. Non-clinical performance testing, and Labeling. 
Scalp discomfort, dizziness, nausea, pain in neck or jaw, headache, or 
other adverse effects due to treatment.Labeling. 
Adverse tissue reaction ............................................................................ Biocompatibility evaluation, and Labeling. 
Electrical shock ......................................................................................... Electrical safety testing, and Labeling. 
Device failure due to interference with other devices .............................. Electromagnetic compatibility testing, Elect rical safety testing, and La-
beling. 
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, 
transcranial magnetic stimulation systems for neurological and psychiatric disorders and conditions 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 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 found in other FDA regulations and guidance. 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 part 820, regarding quality system regulation, have been approved under OMB control number 0910–0073; the collections of information in 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 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 
■1. The authority citation for part 882 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 882.5802 to subpart F to read 
as follows: 
§ 882.5802 Transcranial magnetic 
stimulation system for neurological and psychiatric disorders and conditions. 
(a) Identification. A transcranial 
magnetic stimulation system for 
neurological and psychiatric disorders and conditions is a prescription, non- implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended 
for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive 
transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) Performance testing must 
demonstrate electromagnetic compatibility, electrical safety, and thermal safety. 
(2) Software verification, validation, 
and hazard analysis must be performed. 
(3) The patient-contacting 
components of the device must be demonstrated to be biocompatible. 
(4) Non-clinical performance testing 
must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: 
(i) Magnetic pulse output testing; 
(ii) Magnetic and electrical field 
testing; 
(iii) Testing of the safety features built 
into the device; and 
(iv) Testing of the sound levels 
patients are exposed to during device 
use. 
(5) The physician and patient labeling 
must include the following: 
(i) The risks and benefits associated 
with use of the device; 
(ii) Detailed instructions to prevent 
seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and 
(iii) A description of the ear 
protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating. 
Dated: March 8, 2019. 
Lowell J. Schiller, 
Acting Associate Commissioner for Policy. 
[FR Doc. 2019–04709 Filed 3–13–19; 8:45 am] 
BILLING CODE 4164–01–P 
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