1 Mobile Medical Applications What Is the Impact of FDA s New MMA Guidance for the Life Science Industry? June 6, 2014, 11:15 AM 12:15 PM Presented by: Mark Gardner, M.B.A., J.D.
2 Agenda 1. How does FDA regulate mobile medical applications (MMAs) in light of FDA s new guidance? 2. Practical implications of new guidance What should companies consider when designing, manufacturing and selling MMAs? 3. Updates on MMAs and FDA 4. Questions at the end; please ask as we go too!
3 Martin Cooper invented the cellular phone at Motorola in the 1970s. Things have obviously changed a lot since then!
4 4 Credit: Hykano
5 Mobile Growth is Exponential 500 million users of health care apps by billion users of health care apps by 2018! Some for professional use others for personal
6 HOW DOES FDA REGULATE MOBILE MEDICAL APPLICATIONS?
8 At a Base Not all apps are medical devices just because they have health related functions Calorie counters and fitness apps are NOT MMAs Mobile apps that are medical devices by definition may not be regulated as such due to FDA enforcement policy FDA is focusing on high-risk apps apps that will hurt people if they malfunction
9 A Little History 1989 FDA put out its policy on computer products and software Called the FDA Policy for the Regulation of Computer Products, a.k.a., Draft Software Policy It declared software products were medical devices It was withdrawn in 2005
10 More Recent History 2011 Medical Device Data Systems (MDDS) downclassified from Class III medical devices (high-risk) to Class I (low-risk) on 2/15/ Has led to a great deal of interest in the MDDS space Sept. 25: MMA guidance finalized draft guidance was issued 9/21/2011
11 Definitions (are important) Mobile platform Commercial off-the-shelf (COTS) computing platforms Handheld in nature, e.g., mobile phones, tablets, laptops. Mobile Application (Mobile App), e.g.: My Fitness Pal ihealth WebMD Mobile Medical Application (MMA) Meets definition of a medical device under 201(h) of the FD&C Act; AND either: Accessory to medical device; OR Transforms a mobile platform into a medical device
12 Intended Use is Key in Determining Regulatory Classification Intended use determines if an app is a medical device Medical devices are: intended to treat, cure, prevent, mitigate or diagnose disease; OR intended to affect the structure or any function of the body Device definition at 201(h) of the FD&C Act Intended use (21 CFR 801.4) shown by : Labeling claims Advertising materials Oral / written statements Implied or expressed claims
13 Definitions MMA Manufacturer Includes those that create, design, develop, label, re-label, etc., MMAs Or people that commission the creation of MMAs Includes MMAs that can be accessed over the web Non-MMA manufacturers Makers of apps that have no medical device functions Distributors, e.g., itunes, Android market, are not MMA manufacturers Internet providers, cloud hosting HCPs, making apps for patients Research and teaching medical apps (consider IDE regs.)
14 Scope of FDA Guidance FDA focuses on mobile apps that: (1) meet the statutory definition of a device, under 201(h)*; and (2) are either intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform (e.g., iphone) into a regulated medical device *Recall intended use discussion
15 Practical Reality Many app makers out there have no idea they are actually MMA manufacturers They are making medical devices (MMAs) and do not know it! As a result, many MMAs are misbranded and adulterated These companies face legal and regulatory exposure They are also at a competitive disadvantage
16 Practical Reality Companies that market and manufacture MMAs improperly face FDA enforcement risk Warning Letters Consent Decrees Seizure Publicity Business disruption or effective shut-down can be catastrophic
17 Practical Reality If this is news Get into compliance! Determine regulatory classification MMA? Unregulated mobile app? An app FDA will exercise enforcement discretion regarding? MMAs can be Class I (low risk), II (medium) or III (high) depending on FDA Product Code Among other things, register/list, follow Quality System (QS) requirements, 21 CFR 820 Good Manufacturing Practices (GMPs)
18 Types of Apps that are the Focus of FDA s Regulatory Oversight (1) Apps that are an extension of a medical device via connection (wire or wireless) used to control a device or displaying, storing, analyzing or transmitting patient specific device data Examples: Picture Archiving Communication Systems (PACS) Medical Device Data Systems (MDDS) Apps that control devices, e.g., delivery of insulin via a pump determined by an app blood pressure cuffs being run by apps
19 Example Accessory to a Regulated Medical Device Users can check their blood pressure using a regulated medical device and their iphone or ipad The app controls the cuff via the touchscreen The app also tracks information, e.g., daily read outs
20 Types of Apps that are the Focus of FDA s Regulatory Oversight (2) Apps that transform a mobile platform, e.g., your iphone, into a regulated medical device by using: Attachments Display screens Sensors Or other functions of a phone, e.g., the LED light Some that exist now Others on the horizon!
21 Example Transforming a Mobile Platform into a Regulated Medical Device iphones have an LED light that theoretically could be used by a doctor to examine patients Is my iphone now a medical device? It depends! How is the product marketed? If it is marketed to illuminate general objects, then no, probably not a device If it is marketed as a light source for ophthalmologists to examine patients, e.g., an ophthalmoscope, then the app has transformed my phone into a regulated medical device!
22 More Examples Transforming a Mobile Platform into a Regulated Medical Device Attaching: a blood glucose strip reader to my iphone to function as a glucose meter electrocardiograph (ECG) electrodes to my tablet to measure, store and display ECG signals Using built-in components: phone accelerometer for sleep apnea monitoring sensors for creating an electronic stethoscope Displaying radiographic images for diagnosis
23 Types of Apps that are the Focus of FDA s Regulatory Oversight (3) Apps that become regulated medical devices by performing patient-specific diagnosis or treatment recommendations Apps that calculate dosage plans Apps that give treatment recommendations If you want to avoid being regulated under this classification, consider whether you need to provide patient-specific advice
24 What does FDA enforcement discretion actually mean?
25 Apps for which FDA Intends to Exercise Enforcement Discretion Apps that: (1) help patients self-manage their disease without providing specific treatment or suggestions (general coaching for patients); e.g.: Skill of the Day apps for patients with mental challenges (2) provide patients with simple tools to help them track and organize health data e.g., blood pressure tracking tool (3) provide easy access to information related to patients health conditions or treatments e.g., drug allergy look-up tools
26 Apps for which FDA Intends to Exercise Enforcement Discretion Apps that: (4) help patients document, show, or communicate medical conditions to providers; e.g. a camera used for documenting a wound (5) automate simple tasks for providers; OR e.g., BMI calculation (6) enable patients or providers to interact with records. e.g., Personal Health Record (PHR) or Electronic Health Record (EHR) systems
27 Apps that are NOT MMAs Apps that are generic aids or general purpose products, For example: Using an Android phone as a magnifying glass Such apps cannot be not intended for medical purposes not regulated under 21 CFR , Magnifying Spectacles Record audio, amplify audio
28 Apps that are NOT MMAs Apps that: Provide education/training tools not intended to treat, diagnose or be used clinically Maps to special gluten free restaurants Automate general business functions in an office, e.g., apps that: Determine billing codes and facilitate insurance claims Generate appointment reminders Provide wait times in facilities Help patients pay their medical bills
29 Summary of Apps and FDA Regulatory Oversight Mobile apps that FDA regulates Enforcement discretion mobile apps Mobile apps that FDA does NOT regulate Risk to patients? Low, Medium or High Low Low/none Considered a mobile medical application, i.e., a medical device? FDA Clearance or Approval Required? Additional Regulatory Requirements? Yes Maybe No Perhaps, depending on FDA product code Yes QS, register/list, MDR P&Ps, etc. No No, but encouraged to by FDA No No Example of functions? Intended to diagnose, treat, cure, prevent or mitigate disease? -Controls a regulated medical device -Transforms a mobile platform into a device -Data management -Coaching -Reminders -Documentation -Simple calculations Maybe Maybe No -Audio recording, amplification -Education -Business operations
30 Additional Regulatory Requirements for Class I MMA Makers MMR makers of Class I* devices must follow general controls : Register annually and list devices with FDA (21 CFR 807); Registration fees, 2014: $3313 and 2015: $3750 Comply with the Quality System (QS) regulation (21 CFR 820) Following labeling requirements (21 CFR 801); Medical Device Reporting (21 CFR 803); Must report device failures which caused or contributed to death or serious injury or will in the future *Class is dependent on product code Know your code
31 Additional Regulatory Requirements for Class I MMA Makers (continued) MMR makers of Class I devices must follow general controls : Provide premarket notification if necessary (21 CFR 807); Report corrections and removals (21 CFR 806); and Follow the Investigational Device Exemption (IDE) regulations (21 CFR 812)
32 Additional Regulatory Requirements for Class II & III MMA Makers Class II and III MMA makers must follow all general controls for Class I devices which we just covered Plus: Special controls for most Class II devices Premarket Approval (21 CFR 814) for Class III devices
33 PRACTICAL IMPLICATIONS OF NEW GUIDANCE
34 MMA Company Question Checklist Classification Is the app the type that FDA cares about? Or will FDA use enforcement discretion? Can the app be safely used by a patient without active oversight by a medical professional? If something goes wrong with the app, is it going to hurt someone? Documentation supporting: i) the assigned app product code, ii) why the app is not regulated, or iii) reasons why it fits under the enforcement discretion bucket?
35 MMA Company Question Checklist More on Product Codes If my device is acting as an accessory to a regulated device, or is transforming a mobile platform into a regulated medical device then what Product Code does it fall under? Are the appropriate regulations being followed?
36 MMA Company Question Checklist Claims What is the intended use of the app? If it is an MMA, do the claims match my product code? If it is a Class I app, are claims made which go beyond the CFR it is regulated under? Off-label claims?
37 MMA Company Question Checklist Other regulatory requirements met? Quality System established? ISO 9001, ISO 13485, Special Controls? Policies and procedures in place? Registered and products listed? MDR reporting and documentation in place? Following FDA s recommendation to follow Quality System requirements for enforcement discretion apps? Necessary or not?
39 Latest Intel on MMAs MMA FDA clearance/approval process is lagging The Agency recently defended its tardiness Bakul Patel told the audience that in 80 percent of the cases the agency has met the statutory 90-day timeframe under the 510(k) process Health Data Management Feb. 25, 2014 Some calling for a new legal definition and therefore regulatory class of products, i.e., medical software
40 Latest Intel on MMAs Many new MMAs have been cleared ~100 have been cleared and approved since 1997 Picking up See examples of MMAs FDA Has Cleared or Approved at: ocedures/connectedhealth/mobilemedicalapplications/uc m htm. Many app makers are participating illegally in the market place Investors continue to invest in this new space area of great growth in Silicon Valley
41 The end. Questions? Contact info: Mark Gardner, M.B.A., J.D. (612) Copyright 2014 DuVal & Associates, P.A. All rights reserved.