The US Food and Drug Administration (FDA) has proposed that ingestible medical devices be classified as Class II (moderate risk) medical devices subject to the 510(k) premarket notification process and special controls, clearing the way for their wider clinical use.
Under current federal regulations, new medical devices that have not previously been cleared by FDA are automatically considered Class III (high-risk) medical devices and require the approval of a premarket approval (PMA) application prior to marketing. While some exceptions exist, including the de novo process that allows FDA to down-classify a device based on its probable risk, they are still more onerous than the 510(k) process, which is both cheaper to apply for and more straightforward from a regulatory perspective.
Even subsequent to an initial approval, companies may find themselves hard-pressed to figure out what parts of the device FDA considers to be essential to its functioning, and thus what a successful 510(k) application might look like.
However, FDA has one method it may use to make it easier for an entire class of medical devices to seek approval: It may decide to down-classify a class of medical devices, either subjecting it to general controls (Class I medical devices) or special controls (Class II medical devices) as a means of ensuring that a device is manufactured to appropriate standards.
The primary benefit of such a reclassification is that it clears the way for other manufacturers to focus on meeting pre-specified standards rather than showing the "sameness" of their device relative to an already-approved predicate.
And on 15 May 2013, FDA announced that it was proposing to institute Class II special controls for personal monitoring devices, having already approved its first one in July 2012. That device, the Ingestion Event Marker (IEM), is manufactured by Proteus Digital Health and was cleared via FDA's de novo process in approximately two months' time.
The devices, which some refer to as "smart pills," are essentially very small spheres powered by the body's own electricity-"Just like a potato battery," Proteus remarked on its website. Various biometric data is collected by the device, which is passed on to a wearable patch that can upload information to another device such as a smartphone.
But the real benefit of the product isn't so much its solo use. Rather, it is envisioned that they will be combined with pharmaceutical products, allowing patients and practitioners alike to track rates of adherence and other physiological effects of the drugs. As Regulatory Focus noted at the time, that could be a boon for sponsors of clinical trials, who may find it difficult to determine if a patient has actually consumed a product.
But Proteus reportedly told FDA that the entire process could stand to be expedited in the future, and recommended that the device class be reclassified as a moderate risk subject to special controls. In its Federal Register announcement, FDA agreed with that assessment, saying it is starting the public rulemaking process immediately in the hopes of doing just that.
"FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device," it said in the notice.
The agency took note of eight potential issues with the product class, and recommended a series of mitigation measures be undertaken in the form of special controls, including:
- biocompatibility testing
- labeling (dose limits)
- electromagnetic compatibility testing
- wireless testing
- labeling (incompatibilities)
- electrical safety testing
- labeling (electrical safety issues)
- nonclinical performance testing (electrical or mechanical failures)
- nonclinical Performance testing (failure to mark events)
- clinical evaluations
- animal testing
- human factors testing
- labeling (use and usability)
In addition, FDA said four additional controls will need to be met before a device may be marketed:
- The device must be demonstrated to be 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.
- Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety.
- 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.
FDA clarified that the device will not be exempted from premarket notification, and that sponsors will need to submit a 510(k) to the agency before being allowed on the market.
A comment period will be open for 30 days starting on 16 May 2013.