Home > FDA, research > ACR to Participate in FDA Workshop on Mobile Medical Applications Draft Guidance

ACR to Participate in FDA Workshop on Mobile Medical Applications Draft Guidance

On September 12-13, the American College of Radiology (ACR) will participate in a Food and Drug Administration (FDA) workshop regarding its recently published mobile medical applications draft guidance.

Dr. David Hirschorn (Staten Island University Hospital) of the ACR IT and Informatics Committee-FDA workgroup will be a panelist on the topic of “level of oversight and proposed approach; following current classifications and oversight controls.”  His panel will discuss the following questions about the draft guidance, as well as any additional questions brought up by attendees in the audience:

  • Is the level of oversight appropriate for mobile apps?
  • What part of current requirements needs clarity for mobile medical apps?
  • Is there a different general approach to effectively oversee mobile medical apps?
  • Are there other factors to be considered in effectively assuring safety of mobile medical apps?
  • How best can the guidance provide more clarity to mobile medical app manufacturers?

The workshop will take place at the FDA’s White Oak Campus in Silver Spring, Maryland and will be available to public stakeholders via webcast.

Categories: FDA, research
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