FDA Clears Ingestible Medical Device through De Novo Review Process
On May 1, 2012, the U.S. Food and Drug Administration (“FDA”) cleared the Proteus Digital Health, Inc. (“Proteus”) ingestible sensor for marketing as a Class II medical device through the de novo review process. The ingestible sensor is part of digital health feedback system that will relay information to a patient’s healthcare professional from a microchip embedded in pills to monitor a patient’s response to treatment.
The Proteus ingestible sensor can be integrated into medications such as inert pills or other pharmaceutical products. Once the digested sensor reaches the stomach fluid, it communicates a unique signal to a patch worn on the skin that marks the precise time the medication was taken. The patch also collects physiologic and behavioral information, including heart rate, body position and activity. The patch then relays the information to the patient’s healthcare professional through a mobile phone application. As a result, the ingestible sensor allows healthcare professionals to ensure that patients are taking medications as prescribed while receiving feedback on patients’ physical response to treatment.
Currently, the FDA has only cleared the ingestible sensor based on studies establishing its safety and effectiveness when implanted into placebo pills. However, Proteus hopes to have the device cleared for use with drugs in the near future.
Notably, the ingestible sensor device was cleared for marketing by the FDA through de novo review because it is the first device to monitor medication adherence. The de novo review process is available for novel low- and moderate-risk devices that have been found to be not substantially equivalent (“NSE”) to existing predicate devices as a result of a 510(k) submission. Pursuant to Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the submitter of a 510(k) may, within 30 days of receipt of an NSE determination for that 510(k), submit a de novo petition requesting the FDA to make a risk-based classification determination for the device under Section 513(a)(1) of the FDCA. If the FDA grants the de novo petition, the device is reclassified from Class III into Class I or Class II. Alternatively, if the petition is denied, the device remains in Class III and may not be marketed until approved by the FDA through submission of a Premarket Approval Application (“PMA”). As a result of the ingestible sensor’s clearance and reclassification as a Class II medical device by the FDA through do novo review, industry may now use the ingestible sensor as a predicate device for future 510(k) submissions.
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