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Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Rules and Regulations
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 21
U.S.C. 360ca1. Although the device
was automatically 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 For this device, FDA issued an order on May 29, 2017, finding the Comaneci Embolization Assist Device not substantially equivalent to a predicate not subject to a premarket approval application. Thus, the device remained in class III in accordance with section 513f1 of the FD&C Act when we issued the order.
On September 28, 2017, RapidMedical Ltd. submitted a request for De Novo classification of the Comaneci Embolization Assist Device. 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 April 24, 2019, FDA
issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21
CFR 882.5955.1 We have named the generic type of device temporary coil embolization assist device, and it is identified as a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
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 1TEMPORARY COIL EMBOLIZATION ASSIST DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Infection

Sterilization validation, Pyrogenicity testing, Shelf life testing, and Labeling.
Biocompatibility evaluation.
Non-clinical performance testing, Clinical performance testing, and Labeling.

Adverse tissue reaction
Tissue or vessel damage:
Dissection
Perforation
Hemorrhage
Vasospasm
Thromboembolic event

khammond on DSKJM1Z7X2PROD with RULES

Coils ensnarement

Non-clinical performance testing, Clinical performance testing, and Labeling.
Non-clinical performance testing, Clinical performance testing, and Labeling.

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. We encourage
sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

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
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

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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