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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
airspace at Ardmore, OK. Subsequent to publication, the FAA identified typographic errors that occurred when the notice to proposed rulemaking was transposed to the final rule in the Class E Airspace Areas Designated as an Extension to a Class D or Class E Surface Area and Class E airspace extending upward from 700 feet above the surface airspace legal descriptions. This action corrects those errors.
Class D and Class E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order JO 7400.11F dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D
and Class E airspace designations listed in this document will be subsequently published in FAA Order JO 7400.11.
Correction to Final Rule Accordingly, pursuant to the authority delegated to me, Amendment Class D and Class E Airspace; Ardmore, OK, published in the Federal Register of October 26, 2021 86 FR 59015, FR Doc.
202123008, is corrected as follows:
71.1

Amended
On page 59016, column 2, line 41, amend to read, Airport extending from the 4.3-mile radius of.
On page 59016, column 2, line 60, amend to read, That airspace extending upward from.

Issued in Fort Worth, Texas, on November 29, 2021.
Martin A. Skinner, Acting Manager, Operations Support Group ATO Central Service Center.
FR Doc. 202126187 Filed 12121; 8:45 am BILLING CODE 491013P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 868
Docket No. FDA2021N0622

Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.

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AGENCY:

The Food and Drug Administration FDA or we is classifying the isocapnic ventilation device into class II special controls.
The special controls that apply to the
SUMMARY:

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device type are identified in this order and will be part of the codified language for the isocapnic ventilation devices 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.
DATES: This order is effective December 2, 2021. The classification was applicable on March 14, 2019.
FOR FURTHER INFORMATION CONTACT:
Todd Courtney, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1216, Silver Spring, MD 209930002, 3017966371, Todd.Courtney@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background Upon request, FDA has classified the isocapnic ventilation device 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 device 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
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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 in order 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 August 18, 2017, Thornhill Research, Inc. submitted a request for De Novo classification of the ClearMate.
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
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