With the growing importance and prevalence of mobile devices like smart phones and personal tablets in the health care setting, the governance of these devices has become an important topic. As such, the US Food and Drug Administration (FDA) recently issued its “Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications” in an effort to eventually pass regulations about the topic. This issuance, however, is only a set of recommendations, which is open to public comment through late October.
The draft guidance classifies an application as a mobile medical application if it “meets the definition of ‘device’ in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 4; and either: is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device.” The draft guidance does not address the mobile devices themselves.
“The draft guidance only deals with what they’re calling mobile medical applications and they’re differentiating between that and other mobile apps that may be used for personal health reasons,” said Michael Peters, ACR director of legislative and regulatory affairs. “They’re also exempting things like EHRs and personal health records.
“They only consider a mobile application a medical device if it transforms the platform into something that can be used for treatment.”
This draft guidance is the FDA’s first public explanation of the agency’s thinking on mobile apps, and an early guideline of what will and will not fall under the agency’s jurisdiction. However, it does not ensure that FDA regulations regarding mobile medical applications will appear.
There is good reason to think that regulations will eventually become standard, though. Mobile MIM, a remote diagnostic imaging tool for the iPad, iPhone, and iPod touch, was the first mobile medical application to receive 510(k) clearance from the FDA. The process for clearance of the application, which enables viewing of MR, CT, and PET images, and earned FDA clearance in February two and a half years after it first appeared, offers some insight into the agency’s thinking for future applications.
“I think Mobile MIM going through the process is an indication that people do see a purpose to this and will go through the process to get a product out that consumers can use,” Peters said. “I think the Mobile MIM experience is probably the best—or only—example of companies that have dealt with this process so far.”
While currently the FDA is limiting the scope of the draft guidance to applications that can be used for diagnosis and treatment, the agency has announced that there will be a follow-up guidance that addresses clinical decision support systems and quality systems. The next step in the current process, however, is offering comments to the FDA in order to better define and regulate these mobile medical applications.
“If anyone has significant feelings about the issue and wants to submit input to the ACR for the purpose of our comments, they are free to do so,” said Peters. “Whether or not they’re members of the industry, we’re looking at this issue from every angle. We’d be happy to hear if anyone has anything to say.”
