CDRH intends to finalize its draft guidance on mobile medical applications by the end of the year, according to Center senior policy advisor Bakul Patel. During a radio interview on The Federal Drive in October, Patel noted that the agency’s intention is to regulate those apps with “very high-risk interventions” that could lead to unintended consequences.
So far, the Center has focused on apps that connect to medical devices. For example, one app that it cleared was for an ultrasound wand that connects to a smartphone to make it a portable ultrasound machine. Another app allows doctors to view X-rays on tablets or smartphones.
Patel said it is "unfeasible" for FDA to test every single medical-related app. A risk-based model is being employed so low-risk apps would not be regulated (e.g., calorie- counting apps or apps that promote healthy lifestyles).
CDRH’s draft guidance released in July 2011 says that although FDA has not issued an overarching software policy, it has formally classified certain types of software applications that meet the definition of a device and, through classification, has identified specific regulatory requirements that apply to these devices and manufacturers.
The draft defines a small subset of mobile medical apps that affect or may affect the performance or functionality of currently regulated medical devices. The subset includes apps that (1) are used as an accessory to medical devices already regulated by FDA and (2) transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices.
Commenting on the draft, members of the mHealth Regulatory Coalition said more work needs to be done. In a letter to agency, the coalition says that unlike some who have recommended that the guidance be pulled pending further evaluation of its impact on the industry, it believes that clear, predictable, and narrowly-tailored regulation is necessary to ensure patient safety and promote innovation.
The group says FDA should strive to create a framework that promotes innovation and discovery of new ways to improve care delivery, reduces healthcare costs, facilitates private investment in the mHealth industry by large and small businesses, and stimulates job creation in the U.S. Areas that the coalition believes need the greatest attention as FDA finalizes the guidance include clarity of intended use with a focus on regulating moderate- to high-risk devices; application of the accessory rule; roles and responsibilities of entities involved in mHealth systems; and regulation of software in mHealth.
Meanwhile, Rep. Mike Honda (D-CA) says he will soon introduce legislation to create an FDA Office of Mobile Health to provide recommendations on mobile health app issues. Honda says the office also would create a mobile health developer support program at HHS to help app developers be sure they are operating within privacy regulations.