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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
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.
We believe this De Novo classification will enhance patients access to beneficial innovation. 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 section 513f2Bi of the FD&C Act.
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 section 513i of the FD&C Act, defining substantial equivalence.
Instead, sponsors can use the lessburdensome 510k process, when necessary, to market their device.
II. De Novo Classification For this device, FDA issued an order on November 27, 2012, finding the Medtronic DUETTM External Drainage and Monitoring System EDMS not substantially equivalent to a predicate device and not subject to a premarket approval application PMA. Thus, the device remained in class III in accordance with section 513f1 of the FD&C Act when we issued the order.
On December 21, 2012, FDA received Medtronic Neurosurgerys request for De Novo classification of the Medtronic
DUETTM EDMS. 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 section 513
a1B of the FD&C Act. 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 22, 2014, 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 882.5560.1 We have named the generic type of device cerebrospinal fluid shunt system, and it is identified as a prescription device used to monitor and divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of preventing spinal cord ischemia or injury during procedures that require reduction in central nervous system pressure. A
cerebrospinal fluid shunt system may include catheters, valved catheters, valves, connectors, and pressure monitors intended to facilitate use of the shunt or evaluation of a patient with a shunt.
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 1CEREBROSPINAL FLUID SHUNT SYSTEM RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Pyrogenicity/adverse tissue reaction

Biocompatibility testing, Pyrogenicity testing, Labeling, Shelf-life testing, and Sterility testing.
Labeling, Sterility testing, and Package integrity testing.
Labeling, and Non-clinical performance testing.
Labeling, and Non-clinical performance testing.

Infection including meningitis
Cerebrospinal fluid CSF leakage
Overand under-drainage 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
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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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