New legislation introduced in the US House of Representatives on 22 October 2013 would prevent the US Food and Drug Administration (FDA) from regulating mobile medical apps that do not meet a newly defined regulatory definition of "medical software."
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."
However, when the statute was written, the concept of a smartphone or a piece of mobile software had not yet been envisioned. In the meantime, regulators have been forced to grapple with how best to regulate mobile medical apps and the devices they run on.
The first step toward a formal regulatory paradigm came in 2011, when FDA released a long-anticipated draft guidance establishing which applications the agency would regulate, as well as those it intended to exercise its "enforcement discretion" toward (i.e. not regulate unless warranted).
In general, those applications making disease-specific or curative claims, as well as those that work in tandem with an actual device (such as an app to display the results of an attached ECG), would need to seek FDA approval or clearance prior to marketing. Other health-related apps, such as calorie counters or fitness trackers, would not be required to submit applications for approval prior to marketing.
In September 2013, FDA released the final version of the guidance, Mobile Medical Applications, further clarifying the various subsets of mobile applications it does and does not plan to regulate.
But throughout the entire process of FDA's guidance development, one constant has been the public displeasure of legislators.
In March 2013, that displeasure came to a head, with the House Energy and Commerce Committee holding a hearing to determine if FDA would regulate smartphones and tablets. At issue: Since the safety and efficacy of an app is at least partially contingent upon the actual hardware (i.e. smartphone) it runs on, would FDA choose to regulate that hardware?
In a word: No.
"FDA would not regulate the sale or general consumer use of smartphones or tablets," Christy Foreman, director of the Office of Device Evaluation within the Center for Devices and Radiological Health (CDRH), told legislators at the March 2013 hearing. "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."
Neither would FDA seek to regulate the marketplace for the apps, such as Apple's iTunes store or Google's Google Play, Foreman said.
New Regulatory Definitions
While those words seemed to largely placate legislators, new legislation released on 22 October 2013 indicates that their interest in the topic has not been fleeting.
The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act is intended to give FDA the "necessary tools to appropriately oversee" mobile medical applications while at the same time protecting developers from regulatory overreach or "stifling" requirements.
"Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software. The SOFTWARE Act tailors their authority to the realities of the 21st century by focusing their authority onto the products that pose a potential risk to human health," legislators wrote.
Specifically, the legislation introduces a new legal definition for the term "medical software" under Section 201 of the FD&C Act.
The term would be defined as:
software that is intended for human or animal use and--
`(1)(A) is intended to be marketed to directly change the structure or any function of the body of man or other animals; or
`(B) is intended to be marketed for use by consumers and makes recommendations for clinical action that--
`(i) includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider; and
`(ii) if followed, would change the structure or any function of the body of man or other animals;
`(2) is not software whose primary purpose is integral to the functioning of a drug or device; and
`(3) is not a component of a device.'.
In addition, the legislation also defines the terms "clinical software" and "health software," both of which are explicitly exempted from FDA's regulatory authorities.
While the legislation seems to be in line with FDA's current regulatory paradigm under its recently-released final guidance, it does remove the option for it to revoke its "enforcement discretion" and go after app developers if it felt compelled to do so.
The legislation is co-sponsored by Reps. Marsha Blackburn (R-TN), Gene Green (D-TX), Phil Gingrey (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR) and G. K. Butterfield (D-NC).
The SOFTWARE Act