Voglio sapere a riguardo di…

jspears on DSK121TN23PROD with RULES1

Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations for use with wound dressings classified under 878.4780. This classification does not include devices intended for organ space wounds.
b Classification. Class II special controls. The special controls for this device are:
1 Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
i Wound complication rates; and ii All adverse events.
2 The patient-contacting components of the device must be demonstrated to be biocompatible.
3 Performance data must demonstrate the sterility of the patientcontacting components of the device.
4 Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
5 Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use.
6 Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life:
i Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life;
ii Fluid removal rate consistent with the wound types specified in the indications for use; and iii Timely triggering of all alarms.
7 Performance data must demonstrate the electrical safety and electromagnetic compatibility EMC of the device.
8 Software verification, validation, and hazard analysis must be performed.
9 Labeling must include the following:
i Instructions for use;
ii A summary of the device technical specifications, including pressure settings, modes e.g., continuous or intermittent, alarms, and safety features;
iii Compatible components and devices;
iv A summary of the clinical evidence for the indications for use;
v A shelf life for sterile components;
and vi Use life and intended use environments.
10 For devices intended for use outside of a healthcare facility, patient labeling must include the following:
i Information on how to operate the device and its components and the typical course of treatment;

VerDate Sep<11>2014

15:55 Dec 09, 2021

Jkt 256001

ii Information on when to contact a healthcare professional; and iii Use life.
Dated: December 6, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126741 Filed 12921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 882
Docket No. FDA2021N0595

Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for Attention Deficit Hyperactivity Disorder Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
AGENCY:

The Food and Drug Administration FDA, the Agency, or we is classifying the transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder ADHD
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 transcutaneous electrical nerve stimulator for ADHDs 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 10, 2021. The classification was applicable on April 19, 2019.
FOR FURTHER INFORMATION CONTACT:
Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4208, Silver Spring, MD 209930002, 3017965433, PamelaD.Scott@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Background Upon request, FDA has classified the transcutaneous electrical nerve stimulator for ADHD 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
PO 00000

Frm 00027

Fmt 4700

Sfmt 4700

70375

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.

E:FRFM10DER1.SGM

10DER1