21 CFR 882.5060 — Eating Disorder Conditioning Tool
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5060
Identification
A conditioning tool for eating disorders is a prescription device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OBV | Eating Disorder Conditioning Tool | 2 | 1 |
Special Controls
OBV — Eating Disorder Conditioning Tool
*Classification.* Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing must demonstrate: (i) Device measurement accuracy and repeatability; and (ii) Device feedback accuracy. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (5) Labeling and patient labeling must be provided which includes the following: (i) Information identifying and explaining how to use the device and its components; and (ii) Information on how the device operates and the typical course of treatment.
eCFR
OBV — Eating Disorder Conditioning Tool
(1) Nonclinical performance testing must demonstrate: (i) Device measurement accuracy and repeatability; and (ii) Device feedback accuracy. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (5) Labeling and patient labeling must be provided which includes the following: (i) Information identifying and explaining how to use the device and its components; and (ii) Information on how the device operates and the typical course of treatment.
Ecfr Llm
