Medical Device Software: Establishing FDA Authority and Mobile Medical Apps Seth A. Mailhot, Partner Lead, FDA Regulatory Practice Overview Applying the Definition of a Device to Software Special Categories of Device Software Mobile Medical Applications Responsibilities of Mobile Medical App Manufacturers and Distributors 1
Definition of a Device Sec. 201(h) defines a device as an instrument, apparatus, implement, machine, contrivance,... or other similar or related article, including any component, part, or accessory, which is intended: for use in the diagnosis of disease or other conditions, in the cure, mitigation, treatment, or prevention of disease, to affect the structure or function of the body Software That is Not a Medical Device Electronic copies of medical textbooks, teaching aids or reference materials Software solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness 2
Software That is Not a Medical Device (cont.) Software that only automates general office operations with functionalities that include billing, inventory, appointments, or insurance transactions, such as: Software that performs the functionality of an electronic health record system or personal health record system, including providing patients a means to access their health records Software That is Not a Medical Device (cont.) Software solely used to provide clinicians with training or reinforce training previously received Software that serves as a generic aid to assist users, but is not commercially marketed for a specific medical indication, such as serving as a magnifying glass, recording audio, note-taking, and replaying audio with amplification 3
Exceptions to Non Device Software Categories Software allowing the user to input patient-specific information along with reference material to automatically diagnose a disease or condition is a device Generic aids promoted for medical applications are devices: Software that controls a light emitting diode (LED) on a mobile platform is a general aid if the manufacturer intends the system to illuminate objects generally (without a specific device intended use), but If the LED-controlling software is promoted by the manufacturer through marketing and distribution for use as a light source to examine patients (such as an ophthalmoscope), then the software would meet the definition of a device Implications of FDA Regulation Registration and listing (including user fee) Premarket submission (unless exempt) Design controls (21 C.F.R. 820.30) Other good manufacturing practice requirements (Quality System Regulation) Reporting of adverse events (MDRs) Reporting of recalls (corrections or removals) Other requirements 4
Special Software Related Device Categories Medical Device Data System (MDDS) Mobile Medical Apps Laboratory Information System (LIS) Picture Archiving and Communications System (PACS) Remote Patient Monitoring System Medical Device Data System (MDDS) MDDS is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: The electronic transfer, storage, conversion or display of medical device data of medical device data; Class I, 510(k) exempt (21 C.F.R. 880.6310) 5
MDDS (cont.) MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol MDDS does not include devices intended to be used in connection with active patient monitoring Mobile Medical Application ( App ) Mobile application is either: a software application executed on a mobile platform, or a web-based software application tailored to a mobile platform, but executed on a server Mobile medical application is a mobile app that: Meets the definition of device in section 201(h), and Either: is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device Mobile platform: Commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature 6
Mobile Medical App (cont.) Mobile medical apps fit into the following categories: Displaying, storing, analyzing or transmitting patient-specific medical device data (if data is in original format, regulated as an MDDS) Controlling a connected medical device (accessory) Transforms the mobile platform into a regulated medical device (regulated as the device) Performs patient-specific analysis and diagnosis, or treatment recommendations (regulated same as non-mobile software type) Enforcement Discretion for Mobile Medical Apps FDA will exercise enforcement discretion for mobile apps that are not a mobile medical app, despite meeting the definition of a device FDA will also exercise enforcement discretion for mobile medical apps that: Help patients self-manage their disease or conditions without providing specific treatment or treatment suggestions Provide patients with simple tools to organize and track health information Provide easy access to information related to patients health conditions or treatments Help patients document, show, or communicate potential medical conditions to health care providers Automate simple tasks for health care providers; or Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems 7
Examples of Simple Medical Calculations Enforcement discretion applies to simple medical calculations taught in medical schools and are routinely used in clinical practice Examples include medical calculators for: Body Mass Index (BMI) Total Body Water / Urea Volume of Distribution Mean arterial pressure Glascow Coma Scale score APGAR score NIH Stroke Scale Delivery date estimator Other Mobile Medical Apps Subject to Enforcement Discretion Help patients with diagnosed psychiatric conditions maintain their behavioral coping skills by providing behavioral techniques or audio messages Allow users to inquire about herb and drug interactions Use patient characteristics to provide screening, counseling and preventive recommendations from established authorities Track medications and provide user-configured reminders Allow users to collect blood pressure data and share, track, trend or upload it to a personal or electronic health record 8
Other Common Software Devices Laboratory Information System (LIS) Software that handles in vitro diagnostic data related to patient specimen identification, tests requested, results reported, quality control testing, and other aspects of sample analysis Class I, 510(k) exempt (21 C.F.R. 862.2100) Picture Archiving and Communications System (PACS) Software capable of accepting, transferring, displaying, storing, or digitally processing medical images Class II (21 C.F.R. 892.2050) Remote Patient Monitoring System Software that conditions physiological signals so that they can be transmitted via radiofrequency from one location to another for active patient monitoring Class II (21 C.F.R. 870.2910) Who is a Software Manufacturer? Mobile Medical App Guidance states it is any person or entity that: Creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a mobile medical app software system from multiple components Creates a mobile medical app or a software system that provides users access to the medical device function through a website subscription, software as a service, or other similar means 9
Who is a Software Manufacturer? (cont.) Initiates specifications or requirements for mobile medical apps or procures product development/manufactu ring services from other individuals or entities (second party) for subsequent commercial distribution Who Is Not a Software Manufacturer? Manufacturers or distributors of mobile platforms who solely distribute or market their platform and do not intend (by marketing claims) the platform to be used for medical device functions Providers of tools, services or infrastructure used in the development, distribution, or use of a mobile medical app Licensed practitioners who manufacture or alter a mobile medical app solely for use in their professional practice or group and do not label or promote their mobile medical apps to be generally used by other licensed practitioners or other individuals outside of their group Persons who manufacture mobile medical apps solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution (although they may be subject to IDE requirements) 10
Mobile Medical App Distributors FDA revised the guidance redefining the operators of Google play, itunes store, and BlackBerry App World as online market places The draft guidance initially identified these entities as Mobile Medical App Distributors These entities are potentially exempt from the responsibilities of distributors: owners and operators that are only engaged in providing an online market place that allow mobile medical app manufacturers to commercially distribute their mobile medical apps FDA expects distributors of mobile medical apps who may or may not be a platform or service provider will cooperate with manufacturers in conducting corrections and removal actions QUESTIONS? 11
Seth A. Mailhot 601 Pennsylvania Avenue, N.W. Suite 700 South Washington, D.C. 20004-2601 Phone: (202) 747-9566 Cell: (617) 842-0484 Fax: (202) 347-1819 samailhot@michaelbest.com Seth Mailhot is a partner and lead of the FDA Regulatory Practice Group in Michael Best & Friedrich s Washington D.C. office. His 14 years working in the U.S. Food and Drug Administration (FDA) has provided him a unique perspective when counseling clients on a broad range of matters involving the FDA. Seth s practice includes representation of the medical device, pharmaceutical, dietary supplement, tobacco and food industries, and covers both premarket and post-market issues. His practice is focused on development of premarket submission strategies, and FDA enforcement of good manufacturing practices, both domestically and abroad. Admissions District of Columbia Massachusetts U.S. Patent and Trademark Office Education New England School of Law, J.D., Valedictorian, summa cum laude University of Massachusetts, B.S., Chemical Engineering 23 12