Effective today, the FDA is down-classifying ingestible event markers from the more burdensome Class III into Class II (special controls).
An ingestible event marker is a prescription device used to record time-stamped, patient-logged events, the agency noted. The ingestible component links wirelessly through intra-body communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.
The decision to down-classify this type of device came in response to a May 2012 request from Proteus Biomedical to consider lowering the regulatory bar for its Proteus Personal Monitor including ingestible event marker into Class II.
The federal watchdog agency had originally ordered Proteus’ device be classified into the highest risk Class III because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or to a device which was subsequently reclassified into Class I or Class II.
But, after reviewing information submitted in Proteus’ petition and the medical literature, the FDA determined that the Proteus Personal Monitor including ingestible event marker can be classified into Class II with the establishment of special controls, and on July 10, 2012, the FDA issued an order to Proteus Biomedical
down-classified the device.
The FDA codified the classification of Proteus’ device today and has established that any firm submitting a 510(k) premarket notification for an ingestible event marker will need to comply with a number of special controls.
In addition, the agency determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of an ingestible event marker. Any company that intends to market this type of device must
submit to the agency a premarket notification prior to marketing the device.
The FDA identified a number of risks associated with ingestible event markers, but spelled out ways to mitigate these risks.
The following risks to health are associated with ingestible event markers: adverse tissue reaction, systemic toxicity, electromagnetic incompatibility, electrical safety issues, electrical/mechanical failure, failure to mark event, failure to excrete, and usability.
But, the federal watchdog believes ingestible event markers can show reasonable assurance of safety and effectiveness and risks associated with them can be mitigated with certain special controls, in addition to the general controls.
The FDA requires these devices to show proof that they are biocompatible and non-toxic. 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.
In addition, appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance and
electrical safety.
And, 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.
The agency further noted that ingestible event markers are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device, and that prescription-use restrictions are a type of general controls authorized by the FD&C Act.