Bill Text: MI HR0201 | 2013-2014 | 97th Legislature | Introduced
Bill Title: A resolution to urge the Food and Drug Administration to adopt final regulations pertaining to mobile medical applications.
Spectrum: Partisan Bill (Democrat 4-0)
Status: (Introduced - Dead) 2013-09-03 - Referred To Committee On Health Policy [HR0201 Detail]
Download: Michigan-2013-HR0201-Introduced.html
Rep. Darany offered the following resolution:
House Resolution No. 201.
A resolution to urge the Food and Drug Administration to adopt final regulations pertaining to mobile medical applications.
Whereas, Mobile health-related applications offer many benefits to American health consumers. These mobile medical applications can enhance communication between patients and their doctors; help patients understand the impact of diet, exercise and medication compliance on their health; save money by reducing periods of illness; and facilitate proactive data collection; and
Whereas, The manufacturers, distributers, and developers of mobile medical applications need regulatory certainty in order to develop safe and effective mobile applications. The Food and Drug Administration (FDA) has signaled that mobile medical applications will fall under the agency's authority to regulate medical devices. On July 21, 2011, the FDA issued draft guidelines on how the administration intends to apply its regulatory authority; and
Whereas, Two years later, in 2013, the FDA has yet to promulgate final regulations. Thus, application developers are unable to create mobile medical applications with confidence. They could be subject to indeterminate regulations at any given time, which may retroactively affect an application that has already been developed and distributed; and
Whereas, Due to the rapid growth and potential of the mobile medical application market, it is necessary that the FDA issue its final guidance as soon as possible to ensure public safety and continued development of this market. A final set of guidelines will provide certainty to all mobile medical application developers, help bring these applications to market, and allow American health consumers to access the many benefits of these applications; now, therefore, be it
Resolved by the House of Representatives, That we urge the Food and Drug Administration to adopt final regulations pertaining to mobile medical applications; and be it further
Resolved, That copies of this resolution be transmitted to the Commissioner of the Food and Drug Administration, the President of the United States Senate, the Speaker of the United States House of Representatives, and the members of the Michigan congressional delegation.
