21 CFR 880.6305 — Ingestible Event Marker
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6305
Identification
An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OZW | Ingestible Event Marker | 2 | 8 | SaMD |
Special Controls
OZW — Ingestible Event Marker
In combination with the general controls of the FD&C Act, the Proteus Personal Monitor including Ingestion Event Marker is subject to the following special controls:
De Novo Order DEN120011
OZW — Ingestible Event Marker
*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.
eCFR
OZW — Ingestible Event Marker
(1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.
Ecfr Llm
