If you include the words "US Food and Drug Administration" (FDA) and "Social Media" in the same sentence, it is generally followed by an explanation of how the former has failed to issue guidance on the latter. But yesterday marked FDA's use of social media for something rather novel: to interact with members of industry on the recently released mobile medical applications (mobile apps) guidance.
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), medical devices are defined as being any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is either intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease or intended to affects the structure of any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body."
Thus, because some of the applications are intended to be used "in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease," they are regulated as medical devices.
In 2011, FDA released a draft guidance document, Mobile Medical Applications, with the intent of clarifying some of the numerous questions surrounding its enforcement approach. FDA explained in the draft guidance document that it does not intend to regulate some health applications, namely those applications that merely serve to record basic health functions (such as weight or caloric intake) but are not otherwise involved in disease-specific functions.
But some legislators raised a number of issues with the guidance. Namely: Could FDA come to regulate the smartphone device a medical application runs on? FDA seemed to placate those concerns in March 2013 when Christy Foreman, director of the Office of Device Evaluation within the Center for Devices and Radiological Health (CDRH), assured legislators that FDA had no intent to regulate smartphones or other mobile devices.
"[FDA] would not regulate the sale or general consumer use of smartphones or tablets," said Foreman. "FDA's proposed mobile medical apps policy would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA."
In addition, "FDA's proposed mobile medical apps policy would not consider entities that exclusively distribute mobile medical apps, such as the owners and operators of the 'iTunes App store' or the 'Android market,' to be medical device manufacturers," she added.
Neither would FDA's regulatory framework call for each "minor, iterative product change" to be approved or cleared by FDA under its 510(k) premarket notification process.
New Guidance Raises New Questions
On 23 September 2013, FDA released a final guidance on mobile apps that generally adhered to its previous framework. However, the guidance added an extensive appendix of examples, frequently asked questions (FAQ) and other resources, all meant to clarify what FDA will-and just as importantly, will not-regulate.
FDA said in a statement that it intends to "focus its oversight on mobile medical apps" that:
- are intended to be used as an accessory to a regulated medical device - for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet
- transform a mobile platform into a regulated medical device - for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack
Twitter: Regulatory in 140 Characters or Fewer
But if you still have questions about the guidance, a good place to get answers-other than calling up Bakul Patel, its author-was a Twitter chat hosted by FDA on 26 September 2013.
Hosted under the "hashtag" (denoted by the "#" symbol) "#FDAapps," CDRH staff took an hour to answer various questions posed by app developers, industry watchers and journalists, responding to most with quick replies.
The big news: Don't expect to see much in the way of enforcement for quite some time. In response to a question posed by Regulatory Focus, CDRH said it's currently "focusing on clarifying areas that need oversight and looking for voluntary compliance."
"Our efforts are focused on education and clarity at this time," CDRH clarified in a later tweet. The agency twice refused to address one question posed by Focus: Once it does begin to enforce its policy, how will it do so? Will it be searching through so-called "app stores" run by Apple, Google and others? Or will it rely on reporting by consumers and medical professionals?
CDRH wouldn't say, stating only that it "will allow reasonable time for app developers to be in compliance prior to enforcement actions."
Predictably, many of the questions asked of CDRH focused on enforcement discretion matters-which apps might be regulated, especially in borderline cases. But this, too, raised a question, one posed by Focus: Under what circumstances might FDA alter its enforcement approach, given that it has the authority to do so whenever it wishes to do so?
"We intend to follow this policy unless we have new [information] that raises public health risk," CDRH wrote. "If/when we change policies, we will follow public processes."
"We will evaluate necessary actions depending on public health risk," it added in a subsequent tweet.
FDA Twitter Chat on #FDAapps