MRC Provides Feedback on Drafted FDA Regulations for Medical Mobile Apps

by Holly Shoemaker

In a previous blog, I discussed how the Food and Drug Administration (FDA) proposed regulating medical mobile apps used as devices. I continue to follow the topic and will post follow-up blogs related to the feedback received. When possible, I will devote a blog to each organization who commented on the drafted guidelines. This blog focuses on the feedback provided by the mHealth Regulatory Coalition (MRC), a grouped formed in 2010 to focus on defining what medical mobile apps require regulation. The coalition is made up of telecommunications professionals, cell phone manufacturers, semiconductor companies and medical devices companies.

Summary of MRC Feedback

The organization provided four main areas of concern. Those include:

• Clarity – MRC said the drafted regulations were too broad and could result in too many regulations of medical mobile apps. It suggests the FDA also identify specific products it does not plan to regulate.
• Accessory rule – MRC takes the stance that an accessory that has the potential for use as a medical device still falls into the category of using an app as a device. The organization proposes that the FDA develop new regulations for these types of products.
• Roles and responsibilities – MRC would like the FDA to reconsider who is responsible for which regulatory activities during the pre- and post-market phases.
  
• Software regulations – MRC would like the FDA to ease its proposed software regulations. The organization said that its drafted guidelines could create a high burden for developers. To ease the burden, MRC recommends implementing a standard set of design principles.

In addition to making improvements in the above areas, MRC wants the guidelines to help innovate healthcare delivery, reduce healthcare costs and stimulate jobs.

Concluding Thoughts

MRC makes valid suggestions. The organization’s comments take into consideration the needs of developers, healthcare workers and patients. I will continue to monitor for responses from other agencies, developers, consumers and the FDA.