“Stuck in the 70’s:” Modern Medicine, the FDA and Medical Device Legislation

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Will Congressional bills slated for 2015 review finally bring medical device regulation into the 21st Century?

The year was 1976. Apple was founded, bell bottoms were in, Jimmy Carter was elected President and the Food and Drug Administration (FDA) began its first regulatory measures on medical devices.  The notion of “tech-savvy” Americans had not yet come to fruition, nor had the ubiquity of iPhones and tablets—in fact, no consumer would have known what to do with such a device during this era. Today, increasing numbers of hand-held devices allow us to connect with providers, manage and track medications and organization medical records. In 2013 alone, the Apple Store reported 97,000 mobile health apps in use and over 60% of physicians were using tablets. With these solid numbers marked in the medical sphere, why is the FDA still stuck in 1976?

In a recent article released by Forbes Magazine, John Graham illuminates the FDA’s continued regulation of novel, cutting-edge medical devices under outdated amendments and what this antiquated authority means for new health tools. According to the FDA’s original amendments, a medical device is an “instrument, apparatus, implement, machine…or related article, including any component, part or accessory…” Technologies of the 21^st century, namely smartphones, smartwatches and tablets, don’t seem to fit within this definition in any regard.

Despite the amendments’ verbose restrictions, the FDA has informed patients and providers alike on how it intends to regulate new technologies. With the final guidance for medical mobile apps passed in 2013, the FDA intends to focus its regulatory oversight on only a subset of mobile medical apps that present a risk to patients if they do not work as intended. In the final guidance, the FDA defined the term “mobile medical app” and Congress defined the technologies subject to FDA regulation.

While it appears the FDA is making strides in the right direction, many find its law-related verbiage unsettling. Early-stage startups remain weary over the FDA’s “enforcement discretion,” which includes the self-perceived ability to withhold smartphones, tablets and more. After much discussion at last week’s mHealth Summit in Washington, DC, the consensus is this: the FDA cannot be expected to generate consistent regulatory standards without appropriate legislation. Fortunately for the medical sphere, this may be resolved in the next Congress with the following propositions:

MEDTECH Act: would legislate that electronic health records (EHRs) and other technologies that only store and communicate information are exempt from FDA regulation.

SOFTWARE Act: would define the term “medical software” as software distributed directly to consumers and not integrated with a drug or device but includes the use of a drug or device. Such software would be subject to FDA regulation. The bill also includes the terms “clinical software” (used by medical professionals) and “health software” (used by consumers to store and communicate data but doesn’t include the use of a device). Both clinical and health software would not be subject to regulation.

SOURCE: Forbes Magazine

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