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FDA takes to Twitter for questions on mobile medical apps
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The FDA hosted a Twitter chat Thursday to answer questions about its recent announcement that only mobile medical applications presenting “a greater risk to patients if they do not work as intended” will face close agency scrutiny.
The agency will use “enforcement discretion,” since most mobile applications, or apps, pose minimal risk to consumers, according to its announcement.
An initial FDA tweet said the “use of mobile medical devices to diagnose and treat patients is becoming a reality that can change the shape of health care.” The agency also reminded the Twitter audience that most mobile apps currently available do not require FDA review, but that app users should “expect the same level of safety and efficacy in devices designed for mobile as traditional medical devices.”
One questioner asked the agency how it will oversee mobile apps that make simple dosing calculations “routinely used in clinical practice.” The FDA representative tweeted in response that “making recommendations that change dosage would raise risk to consumers.”
A sampling of other tweets and the FDA’s responses:
Q. Under what circumstances would the FDA choose to alter its enforcement discretion paradigm as explained in the guidance?
A. We intend to follow this policy unless we have new info that raises public health risk.
Q. What type of clinical studies/trials will mobile medical devices undergo if they do present a potential risk?
A. Depends on risk of the device and patient exposure.
Q. Can app development templates be approved to make development of new apps easier? How long does app review/approval typically take?
A. On average it has taken 67 days for clearance, but it depends on the complexity and functionality of the app.
FDA officials did not answer questions about specific apps during the 1-hour session, offering an email address for questions about specific apps: mobilemedicalapps@fda.hhs.gov.
The FDA’s final guidance for app developers means that the FDA will not enforce requirements under the Federal Drug and Cosmetic Act for the majority of mobile apps. Since it issued draft guidance in July 2011, the FDA received more than 130 comments, most supporting the tailored approach to oversight, according to the announcement.
The chat can be reviewed online at Twitter.com, #FDAapps.