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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
effectiveness of the device. We believe this action will also enhance patients access to beneficial innovative devices.
DATES: This order is effective December 2, 2021. The classification was applicable on May 20, 2019.
FOR FURTHER INFORMATION CONTACT: Erin Keegan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1649, Silver Spring, MD 209930002, 2404026534, Erin.Keegan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background Upon request, FDA has classified the trunk and limb electrical stimulator to treat headache 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, 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. 360cf1. 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 513i of the FD&C Act 21
U.S.C. 360ci 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 510k of the FD&C Act 21 U.S.C.
360k and part 807 21 CFR part 807.
FDA may also classify a device through De Novo classification, a common name for the process authorized under section 513f2 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. 112144. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510k for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513f1 of the FD&C Act, the person then requests a classification under section 513f2.
Under the second procedure, rather than first submitting a 510k 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 513f2 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 513a1 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.
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 510ks see 21 U.S.C. 360cf2Bi.
As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device
see 21 U.S.C. 360ci, defining substantial equivalence. Instead, sponsors can use the less-burdensome 510k process, when necessary, to market their device.
II. De Novo Classification On November 6, 2018, Theranica Bioelectronics Ltd submitted a request for De Novo classification of the Nerivio Migra. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513a1 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.
360ca1B. 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 May 20, 2019, 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 882.5899.1 We have named the generic type of device trunk and limb electrical stimulator to treat headache, and it is identified as a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patients head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
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 1TRUNK AND LIMB ELECTRICAL STIMULATOR TO TREAT HEADACHE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Adverse tissue reaction
Electrical, mechanical, or thermal hazards that may result in user discomfort or injury e.g., electrical shock or burn..

Biocompatibility evaluation.
Non-clinical performance testing; Electrical, mechanical, and thermal safety testing; Electromagnetic compatibility EMC testing; Software verification, validation, and hazard analysis; and Labeling.
EMC testing, and Labeling.

Interference with other devices
1 FDA notes that the ACTION caption for this final order is styled as Final amendment; final order, rather than Final order. Beginning in December 2019, this editorial change was made to
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indicate that the document amends the Code of Federal Regulations. The change was made in accordance with the Office of Federal Registers OFR interpretations of the Federal Register Act 44

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U.S.C. chapter 15, its implementing regulations 1
CFR 5.9 and parts 21 and 22, and the Document Drafting Handbook.

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