Source: http://www.federalregister.com/Browse/Document/usa/na/fr/2019/3/14/2019-04709
Timestamp: 2019-03-24 10:04:50
Document Index: 690720077

Matched Legal Cases: ['art 807', 'art 807', 'art 820', 'art 814', 'art 807', 'art 801']

84 FR 50 pgs. 9228-9230 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions
Type: RULEVolume: 84Number: 50Pages: 9228 - 9230
Docket number: [Docket No. FDA-2019-N-0396]
FR document: [FR Doc. 2019-04709 Filed 3-13-19; 8:45 am]
Pages: 9228, 9229, 9230
[Docket No. FDA-2019-N-0396]
Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions
[top] 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 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.
This order is effective March 14, 2019. The classification was applicable on August 16, 2018.
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.
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.
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.
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.
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.
[top] 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.
Seizure Non-clinical performance testing, and Labeling.
Thermal injury Non-clinical performance 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, Electrical safety testing, and Labeling.
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)).
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.
21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 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.
(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(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.
[FR Doc. 2019-04709 Filed 3-13-19; 8:45 am]