The U.S. Food and Drug Administration (FDA) will hold a public workshop on its draft guidance proposal for the regulation of mobile medical applications on September 12 and 13 at its White Oak Campus in Silver Spring, MD.
The purpose of the workshop is to provide a forum for discussion with the FDA and to encourage public comment from interested stakeholders on aspects of the agency's draft guidance document published in July 2011. Topics will also include standalone software that provides clinical decision-support functionality, and how the FDA should approach accessories and mobile medical applications that are accessories to other medical devices.
In addition to the public workshop, which will be delivered as a webcast, the FDA is encouraging vendors, healthcare providers, and interested individuals to submit electronic or written comments on how the draft guidance may support the balance between promoting innovation and ensuring safety and effectiveness. The deadline for submitting comments is October 19, 2011.
To submit electronic comments on the draft guidance, click here.
