Mobile Medical Apps - Overview for Manufacturers
Accessibility, availability, cost effectiveness and higher efficiencies are prompting manufacturers and customers to adopt mobility as Next Generation of Medical care. Mobility brings in self-empowerment. It will forever change how healthcare is delivered. There are some 40,000 mobile medical apps downloadable for use. Mobile medical business is estimated to grow to $11.8 billion by 2018 due to rapid use of smartphone; which is expected to grow at a compound annual rate of 39%. Smartphone is the most popular technology among doctors since the stethoscope. In spite of these advantages currently these mobile medical apps stands as a glimmer of light at the end of the tunnel. The primary reason is the highly regulatory environment in which it operates and the high stakes involved (Human Safety, Litigations etc.). There is still some uncertainty on applicable regulations, lack of clear guidance from regulatory agencies and validation bottlenecks.
This blog provides an overview of the regulatory requirements a manufacturer of the mobile medical app need to fulfil before he can market/publish his App in an App Store.
FDA Guidance -
As described in the final guidance document from FDA, it will not include all mobile apps under its ambit and will include only those that are developed as medical devices and whose functionality could pose a risk to a patient's safety if it does not function as intended. The definition of medical devices is for those mobile apps that meet the statutory definition of a device and either is intended:
· to be used as an accessory to a regulated medical device; or
· to transform a mobile platform into a regulated medical device.
If a mobile app is used as a medical device i.e. for diagnosis of disease or cure/treatment or preventing the disease then it will be considered as a Medical device irrespective of which platform it is built. For such Mobile Medical Apps same regulatory standards and risk-based approach will be applied by FDA as it does for other medical devices.
In the past FDA has cracked down on mobile apps which fell short of FDA standards. A Mobile app called uChek, which uses an algorithm and the iPhone's camera to perform urinalysis was banned by FDA since the makers lacked the agency's clearance to market those capabilities, and it fell short of typical FDA standards. The agency sent them a letter requesting them to discontinue marketing of this application till they come into compliance.
Responsibilities of App Manufacturer
Manufacturer means the legal entity that is responsible for design, development, manufacturing, packaging and labeling the Mobile Medical App. A manufacturer of all Mobile Apps must follow the Quality System regulations and GMP in their design and development as recommended by FDA. Whenever required they should initiate corrections to their Mobile Medical apps to prevent patient and user harm. To ensure this their development life cycle should include through testing and validation to show that their application is not only safe but also does what it claims to do. The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
· Establishment registration- 21 CFR Part 807
· Medical Device Listing - 21CFR Part 807
· Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA) - 510(k) - 21 CFR Part 807 Subpart E 21 CFR Part 814
· Investigational Device Exemption (IDE) for clinical studies - 21CFR Part 812
· Quality System (QS) regulation- 21 CFR Part 820
· Labeling requirements - 21 CFR Part 801
· Medical Device Reporting (MDR)- 21 CFR Part 803
Mobile apps for which the FDA intends to exercise enforcement discretion
FDA has prescribed a Risk based approach to regulate the approval of Mobile Medical Apps. The apps that are classified as "device" but pose minimal risk to consumers and patients will come under enforcement discretion of FDA and FDA will not expect the manufactures to register and list their app with FDA or to submit premarket review applications. For a detailed list of examples of these types of medical apps that do not require FDA review, please visit the webpage Examples of Mobile Apps for which the FDA will exercise enforcement discretion.
Does the FDA regulate mobile devices and mobile app stores?
The answer is "No". FDA's policy for mobile medical apps does not regulate the use or sale of tablets and smartphones. It also excludes the entities that distribute these apps on their portals e.g. Apple iTunes, Google Play Store and does not consider their owners and operators to be medical device manufactures. FDA is very clear in their policy that just because the mobile platform is used to run a mobile medical app it will not hold the mobile platform manufacturer responsible for validation or qualification of the app. It will be the sole responsibility of Mobile Medical App manufacturer to ensure the app is regulated and approved by FDA. The mobile medical app manufacturer is responsible to publish the app on those mobile platforms suitable to run the mobile medical app as intended.
Does the guidance apply to electronic health records?
The answer is again "No". FDA's policy for mobile medical app does not apply to those apps that are used to capture personal health records and used as electronic health record system (EHR). These systems are used to capture the health data and it is the responsibility of the patients and healthcare professionals to assess the functionality of the app and make decisions based on that to use it.
Applications in US vs. Europe -
In Europe the approval of the medical devises is through Notified Bodies and not through national authorities like FDA in US. Notified Bodies are the commercial organizations registered by national authorities to classify and license medical devices. They help the Mobile Medical App manufacturers in classifying their application and complying with the regulatory requirements. So, essentially it is easier to get the mobile medical app published in EU compared to US.
Infosys further interprets regulations for medical software application manufacturers to promote innovation and keep consumers safe in light of changing technologies. We have a Mobility Center of Excellence (MCoE) which will help an organization:
• To access various mobility solutions and come up with a mobility strategy
• To define the process framework required to meet the objectives
• Assist and Guide the innovator companies who are not familiar with FDA's requirements and regulations applicable to medical device manufacturers.
• Clarifies any uncertainty with respect to assigning risk level to medical app.
• Help mobile medical app manufactures to interpret regulatory guidelines when it comes to software updates which would require FDA review
• Helps to validate and quality the mobile medical app and get approval from FDA
• Helps in classifying a new functionality which has never been approved by FDA and help define the regulatory requirements from FDA
We have developed a Regulatory Control Matrix which maps all regulatory requirements to the system related controls (Software/Platform/Network etc.) which includes a comprehensive test suite to test those requirements. We have identified this as a potential growth area and have invested from our side to build the required competencies.
Created with inputs from Aruna Deshmukh