MOBILE MEDICAL APPLICATIONS REVIEWING FDA GUIDANCE FOR INDUSTRY USE

Transcription

1 MOBILE MEDICAL APPLICATIONS REVIEWING FDA GUIDANCE FOR INDUSTRY USE Mike Vanderboom, JD Contract Analyst Office of Grants & Contracts The Medical College of Wisconsin, Inc. 1

2 Introduction Mobile Applications, an FDA issue? In the realm of Mobile Medical Care, yes! More Regulations? No. Nonbinding, sub-regulatory guidance (SRG). Applying. 2

3 201(h) of the Food, Drug & Cosmetic Act Used to protect customers as new healthcare products are developed. Applied to mobile applications in lieu of now defunct Draft Software Policy. How is it applied? SRG. 3

4 201(h) of the Food, Drug & Cosmetic Act Purpose of applying the FD&C Act to Mobile Medical Applications (MMAs)? Certain MMAs can pose potential risks to public health that are unique to the characteristics of the platform on which the mobile medical app is run. Purpose of the SRG? Clarify the distinctions the FDA has determined as relevant to MMA Classification. 4

5 The Basics Definitions are key: Mobile Platform; Mobile Application (App); Mobile Medical App (MMA); Regulated Medical Device ( 201(h) of the FD&C) MMA Manufacturer 5

6 Mobile Platform A commercial off-the-shelf computing platforms, with or without wireless connectivity, that are handheld in nature. Examples include mobile computers such as smart phones, tablet computers, or other portable computers. 6

7 Mobile Application (App) A software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server. 7

8 Mobile Medical Application (MMA) A mobile app that meets the definition of device in 201(h) of the FD&C AND is intended to be used as an accessory to a regulated device; OR To transform a mobile platform into a regulated medical device. 8

9 Mobile Medical App Manufacturer Any person or entity that manufactures mobile medical apps in accordance with the definitions of manufacturer in 21 CFR Parts 803, 806, 807, and 820. May include anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. 9

10 Regulated Medical Device A product that meets the definition of device in 201(h) of the FD&C Act. This definition states 10

11 201(h) of the Food, Drug & Cosmetic Act Defines a device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or in the United States Pharmacopeia, or any supplement to them, (2) 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 (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 11

12 Device, 201(h), in English Boils down to A tool or piece of equipment intended for medical use. 12

13 This means? Under the FDA s guidance, Mobile Medical Applications may be subject to device regulation if they are intended for medical use in certain contexts. Key Investigations: Intent Context 13

14 In Practice 2 Steps to Determine Context The Guidance: context based determination is key. Step 1: Determine whether the Mobile App transforms a Mobile Platform into a medical device. LED example Step 2: Determine whether this new functionality can pose a risk to patient safety if the app malfunctions. 14

15 FDA s Conclusion: The FDA will consider regulating MMAs if a risk to patients is likely. To limit grey area, the FDA has clarified 3 categories of Apps. These categories are applications the FDA: Intends to regulate; Intends to exercise regulatory discretion towards; Does not consider MMAs. 15

16 Examples: MMAs that will be regulated MMAs that are an extension of medical device(s) and connect to the device for the purpose of controlling the device or for use in active patient monitoring or analyzing medical device data: Apps that control a blood pressure cuff; Apps that display patient-specific medical device data. 16

17 Examples: MMAs that will be regulated MMAs that transform the mobile platform into a device by using attachments, display screens or sensors or by including device functionalities: Apps that function as blood glucose strip readers; Apps that attach ECG electrodes and measure/store/display ECG signals; Apps that function as a electronic stethoscope. 17

18 Examples: MMAs that will be regulated MMAs that perform patient-specific analysis and provide patient specific diagnosis or treatment recommendations. Apps that function as dosage calculators or that create dosage plans. 18

19 Examples: MMAs & Enforcement Discretion Apps that: log or track event measurements; coach patients or promote strategies; Provide drug interaction or allergy look up tools; Serve as videoconferencing or communication portals; Perform clinical calculations (BMI/Delivery Date) Provide access to HER systems or patient records. 19

20 Examples: Apps that are not devices Apps that: Provide access to e-copies of medical textbooks; Are intended for educational use (flash cards, interactive anatomy quizes); Automate general office operations in the health care setting (billable hours, insurance claim collection); Apps that are generic aids or general purpose products (magnifying glass, audio note taking, maps to medical facilities) 20

21 Questions? 21