FDA officials opened up on Twitter last night, answering public questions and reinforcing one primary message about the newly released guidelines for regulation of mobile medical applications: FDA wants to stay out of the way.
The agency reinforced that regulation was designed to be hands-off, asking for voluntary participation from relevant apps and requiring no action from others.
"FDA’s final MobMed guidance supports innovation & protects consumers," the agency tweeted more than once.
The FDA emphasized its reliance on "enforcement discretion," which it defined as "not actively enforcing requirements for manufacturers to register & list with the FDA."
The agency had said, when it released its final rule earlier this week, that regulation would only apply to a subset of mobile medical apps that were deemed at increased risk to consumers. Apps that will get more attention include those that are developed as an "accessory" to a regulated device, ones that help healthcare providers view images for analysis and diagnosis and programs that effectively "transform" a mobile device into a medical device, such as smartphone-based heart rhythm monitors.
For apps that fit the criteria of a regulated medical device but post little risk to consumers, the agency plans to prescribe enforcement discretion.
"Now we r focusing on clarifying areas that need oversight and looking for voluntary compliance," the FDA said during last night’s chat, adding that most mobile medical apps already on the market would not require FDA review.
Other noteworthy tweets:
@FDADeviceInfo Can #app developmnt templates be approved to make dev of new apps easier? How long does app rev/appr typically take? #FDAapps
— Dale Cooke (@PhillyCooke) September 26, 2013
@phillycooke on average, it has taken 67 days for clearance but it depends on the complexity and functionality of the app #FDAApps
— FDA Medical Devices (@FDADeviceInfo) September 26, 2013
We will review MobMed in a way that balances risks/benefits w/out creating unnecessary burden for app developers #FDAApps
— FDA Medical Devices (@FDADeviceInfo) September 26, 2013
The FDA guidance reflects our focused priorities on apps that pose greater risks to patients & is a big de-regulatory action #FDAApps
— FDA Medical Devices (@FDADeviceInfo) September 26, 2013
How will FDA be monitoring apps for compliance? Browsing the Apple/Google Play stores? Consumer reports? #FDAApps cc: @FDADeviceInfo
— Alexander Gaffney (@AlecGaffney) September 26, 2013
@alecgaffney– our efforts are focused on education and clarity at this time #FDAApps
— FDA Medical Devices (@FDADeviceInfo) September 26, 2013
@FDADeviceInfo R #mobmed #FDAapps devs responsible for paying #obamacare medical device tax?
— Dale Cooke (@PhillyCooke) September 26, 2013
@phillycooke FDA is a public health agency- pls refer tax questions to IRS #FDAApps
— FDA Medical Devices (@FDADeviceInfo) September 26, 2013
See the full conversation on Twitter at #FDAApps.
