Remember The Jetsons an animated sitcom set in 2026 that suggested the idea of food capsules, space travel, and more importantly, digital medicine Looks like the FDA is preparing for any such futuristic possibilities!
Recently, the FDA granted 510(k) clearance to an ingestible biomedical sensor
that allows remote monitoring of patient medication and other vital signals. Besides this, more than 75
mobile medical applications (MMAs) have been 510(k) cleared by the FDA (even though about 40,000
MMAs are currently available in the iOS and android markets). FDA-regulated MMAs could bring about new levels in safety, credibility, product quality, and user acceptance. On the other hand, this would significantly affect tech start-ups in their pricing, production costs, timelines, and profitability. These developments have encouraged a new generation of doctors to start their own independent peer review journals for MMAs, including the Journal of Mobile Technology in Medicine
. No wonder the regulatory environment surrounding MMAs remains somewhat of a topic of debate within the industry.
Currently, the regulations on MMAs are similar to those for medical devices. On July 2011, the FDA first brought in a detailed draft guideline
on MMAs along with regulatory requirements. These guidelines help to determine which of the existing mobile applications are to be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval) devices. Class I devices or MDDS (Medical Device Data Systems) are considered to be the least risky and the FDA has exempted them from any regulatory requirements. Applications that provide electronic transfer, storage, or display of medical device data qualify to be class I devices. Class II devices would require filing for 510(k) clearance and include products such as mobile platforms that display radiological images for diagnosis. Class III devices require a PMA and may even have clinical trial requirements if they are novel (with no predicates). Also, any MMA would need to be FDA approved if it is an extension of an FDA-approved and regulated medical device; this is also termed as an accessory.
While the MMA industry alone is predicted to grow by 25%
over the next few years, the average 510(k) application review process takes 130 to 180 business days! Will the FDA alone be able to control and regulate the upcoming surge of MMAs. Will the fast-paced mobile application industry be able to adapt to these regulations, Or will this bring about the formation of an independent governing body... Only time will tell.