Regulatory Landscape For Mobile Medical Apps (MMAs)

Transcription

1 Regulatory Landscape For Mobile Medical Apps (MMAs) Date: December 6, 2013 Place: Erie County Bar Association, MidDay Learning Program Where value is law. Monika Bhatt Blog: GatewayFDA.com ATTORNEYS LLP Hodgson Russ LLP #

2 1. Mobile medical apps are changing healthcare Economy and technology. Booming industry It is estimated that 500 million people would use medical apps by The mobile health services market is expected to reach $26 billion by A Brookings Institution analysis found that remote monitoring technologies could save as much as $197 billion over the next 25 years in health care costs. Lack of general awareness among software developers and investors about regulatory implications. If an app is a medical device then it may be subject to Medical device tax. FDA fees and approval timeframes can have a significant impact on the commercialization of a technology. 2

3 2. FDA History: Software Regulation 1989 Draft guidance FDA Policy for the Regulation of Computer Products published 1989 Guidance withdrawn in Proposed FDA rule to reclassify certain software 2011 Final FDA rule to reclassify Medical Device Data Systems (MDDS) from Class III to Class I 2011 Draft guidance Mobile Medical Applications published 3

4 2. FDA History: Software Regulation (cont d) Congressional hearing in March 2013 Focused on Industry and FDA concerns Industry concerns: impact of regulatory burden on innovation in technology, app developers operate under low profit margins, applicability of Obamacare s 2.3% medical device tax on mobile apps. FDA concerns: limited resources to handle the flood of new apps. September 25, 2013 FDA issued Final Guidance on Mobile Medical Apps. 4

5 3. What is a Medical Device? Any product can become a medical device. All it takes is an intended use that meets the legal definition of a medical device. Medical devices range from simple tongue depressors to complex pace makers. Legal Definition of a Medical Device (Section 201(h) FD&C Act). an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man. EXAMPLES: Smart phone, RFID chip, hardware, software, firmware, or any combination. 5

6 4. FDA regulated medical device software may be: Component of a more complex finished device Component of an accessory to a finished device Stand alone finished device Stand alone accessory Firmware, software, GUI, Mobile App, cloud, etc. 5. If a particular software is a medical device then it is still subject to the FDA regulations regardless of the means by which the software is delivered to the end user, whether factory installed, installed by a third party vendor, field installed or upgraded, on a compact disc, on a memory stick, downloaded from a website. 6

7 6. Regulatory process and time frame for a medical device FDA regulates all medical devices through Center for Devices and Radiological Health (CDRH) Steps involved in Regulatory Analysis: Is the product a medical device? Look for its intended use. Who is the Manufacturer? How should the device be classified? What is the risk? Medical devices are divided into three classes for regulatory purposes [Classes I, II and III]. Classification determines regulatory pathway, approval time frame, quality system requirements, etc. for a medical device. Same classification scheme applies to medical device software and MMAs. 7

8 7. Intended use of a device is determined by the objective intent of the people responsible for marketing the device. 8. Who is regulated: Designer ( Specification Developer ); manufacturer (Finished Devices); contract manufacturers (Finished Devices); repackager/relabeler (private labeled Devices); importer ( Initial Distributor ); entity that handles complaints for U.S. distributed devices. 8

9 9. Consequences of marketing without regulatory compliance Product liability Misbranding Department of Justice investigation Anti kickback False claims Import detentions 9

10 10. What must a regulated entity do? Register facility with FDA and list the products with the FDA. Obtain pre market approval from the FDA if a product requires one (pre market approval applications: 510k for Class II and PMA for Class III devices). Pay necessary government fees. Follow FDA s Quality System Regulations (QSR), which lay down standards for all aspects of designing, manufacturing, post market surveillance, etc. for a medical product. Meet FDA s labeling requirements. Prepare for an FDA inspection. Follow FDA s procedure and timelines for reporting injuries relating to the product. Follow product recall protocols. 10

11 11. CDRH s Guidance Design Control Guidance For Medical Device Manufacturers Software Validation Guidance Pre Market Notification Software Guidance Off the Shelf software Guidance Cyber security Guidance 11

12 12. Mobile Medical Apps Guidance Mobile Platforms are not generally regulated unless they are marketed as a medical device. Therefore, the following are generally exempt from FDA regulations: Commercial off the shelf (COTS) computing platforms, with or without wireless connectivity. iphone, BlackBerry phones, Android phones, tablet computers, or other computers that are typically used as smart phones or personal digital assistants (PDAs). 12

13 12 (a). Mobile Medical Apps (cont d) Who is a Mobile Medical App Manufacturer? Anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components. Creates a mobile medical app intended to be used on a mobile platform, or that manufactures a mobile app to be supported by hardware attachments to the mobile platform with a device intended use. Provides mobile medical app functionality through a web service or web support for use on a mobile platform. 13

14 12 (b). Mobile Medical Apps (cont d) Who is Not a Mobile Medical App Manufacturer? Companies that are exclusive distributors of mobile medical apps because they are exclusive distributors of all apps for a specific mobile platform Example: Apple itunes Store Example: BlackBerry App World 14

15 12 (c). Mobile Medical Apps (cont d) Three categories of mobile Apps: Apps that are not regulated by the FDA, Apps under enforcement discretion of the FDA Apps that are regulated by the FDA [See the hand out for examples in each category] 15

16 12 (d). Mobile Medical Apps (cont d) 510(k) Exempt Device: MDDS MDDS is a device that electronically transfers, stores, coverts from one format to another, and displays medical device data without itself controlling or altering the functions or parameters of any connected medical devices. MDDS Classification New: Class 1 Old: Class 3 New: 510(k) Exempt Old: PMA New: FDA Product Code OUG Old: None New: 21 CFR MDDS Old: None 16

17 12 (e). Mobile Medical Apps (cont d) IS REGULATION A BURDEN OR STRATEGY? FDA s first enforcement action against a mobile app developer in May 2013 Biosense Technologies manufacturer of UChek, mobile app that allows a mobile phone to function as a dipstick reader for urine analysis What is the current state of affairs? Bigger companies vs. start ups. Take away Any product can become a medical device all it takes is an intended use that meets the definition of a medical device. 17

18 References: edicalprocedures/connectedhealth/mobilemedical Applications/ucm htm bile_health_52212.pdf ou/industry/ucm htm 18

19 Thank You Monika Bhatt, Esq. Hodgson Russ LLP 140 Pearl Street, Suite 100 Buffalo, New York (716) Blog: GatewayFDA.com 19