Post on 28-Nov-2014
description
Does your Mobile App need FDA Approval?
Cynthia Phelps
July 16, 2013
Why does the FDA care?
The FDA is charged with protecting and advancing the public health
Food, Drug and Cosmetic Act of 1938
They regulate:
• Biologics (blood supply), Cosmetics, Drugs, Food, Radiation products, Veterinary Products AND
• Medical Devices
Software FDA regulates
Medical Device Software
Productions System Software
Quality System Software
Electronic Medical Records Software
Clinical Investigations Software
Classification
Products that are clearly NOT
regulated by the FDA
Medical Devices ARE clearly
regulated by the FDA
GREY AREA
Products not regulated
Not regulated:• Hospital Network devices• Data storage devices• Computer Monitors• Software that monitors device malfunction
Regulated Products
Medical Devices ARE regulated
by the FDA
Regulated Products
Grey Area – FDA Guidelines
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
Not yet approved by Congress
What is a Medical Device?
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory, which is intended for the diagnosis, of disease, or in the cure, mitigation, treatment, or prevention of disease in man or animals, or intended to affect the structure of function of the body of man or animal.
Is your App a Medical Device?Does your App:Amplify CureAnalyze DetectInterprets DiagnoseAssess ManipulateCalculate MeasureControl ProgramConvert Show trends?
What is the intended use?
Is it a part of an existing medical device?
Is it an extension of a medical device?
Does it diagnose, treat, mitigate, or prevent a disease?
Mobile App Criteria
Extensions of Devices
Transform Apps to Devices
Data Input Devices
Extensions of Devices
Apps that serve as extensions of regulated devices such as those that:
control the devices or
display data from the devices
Analyze data from the devices
Transmit data from these devices
Transform Apps to Devices
Apps that serve to transform mobile platforms into medical control by using:
Attachments
Similar medical device functions
Data Input Devices
Apps allow users to input patient data to:
Output patient specific results, or
Diagnose
Using formulae or algorithms
OMG
Class I Class II Class III
OMG You better have stacks of cash and a boat load of patience
It’s ok, you can ride someone’s coattails
No worries the FDA have bigger fish to fry
The Skinny
Class I Class II Class III
3+ Years
FDA review
PMA application
2+ Months
FDA review
510(k) application
No Formal Review
Register Online
Timeline & Process
Class III
• Highest risk
• Your app qualifies as a medical device
• There is no existing medical device precedent for your App
Class II
• Medium Risk
• You app counts as a medical device
• There are other FDA approved medical devices like yours
Class I
Lowest Risk
Your App is exempt from pre-market notification requirements (510(k)) in the US
MDDS – Medical Device Data Systems (2001)
Category of devices used to transfer, store, convert, or display medical device data.
No diagnosis or treatment
No altering the function or controlling the function of a medical device
Device Classification
Go to:www.fda.gov/medicaldevices
Go to:Search bar, type in Product Classification
Enter a search term in the device field:(Guess using the most general search term possible)
FDA Guidelines not Final
FDA, ONC and FCC are developing a report to be delivered to Congress by September that includes:
“a strategy for coordinating the regulation of health information technology in order to avoid regulatory duplication” and
“recommendations on an appropriate regulatory framework for health information technology, including a risk-based framework.”
Discourage Innovation in Healthcare
Latest news: http://mobihealthnews.com/23305/final-days-of-waiting-for-fda-mobile-medical-app-guidance/
FDA Scorecard
1. Number of FDA regulated medical apps reviewed to date: 100 mobile medical apps to date (June 2013)
2. Time it takes for apps to get through 510(k): About 67 days for most mobile medical apps.
3. Number of medical apps seeking clearance each year: FDA only reviews about 20 mobile medical apps each year through its medical device regulatory process.
4. No Class III mobile medical apps yet: The FDA has not found any mobile medical apps to be Class III medical devices yet.
5. When will the final guidance on mobile medical apps be published? That’s a good question, September.
HEALTHeDesigns LLC
Cynthia Phelps, PhDFounder
HEALTHeDesigns@gmail.comwww.HEALTHeDesigns.com