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Recent Developm ents in Medical Device Softw are Overview of Mobile Medical Apps and Medical Device Data System s February 14, 2016 John Grimes, Ph.D. U.S. Food and Drug Administration Center for Devices and Radiological Health Office

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February 14, 2016 John Grimes, Ph.D. U.S. Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health Division of Program Operations and Management Digital Health Team

Recent Developm ents in Medical Device Softw are – Overview of Mobile Medical Apps and Medical Device Data System s

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SLIDE 2

Goals for Today

This talk is meant to help you if …

  • You want to develop a great new app
  • You are not sure if your app is regulated by FDA
  • You want to know what your responsibilities are

What we are going to do: I. Develop a common vocabulary for medical devices

  • II. Discuss how the Mobile Medical Apps (MMAs)

Guidance may affect your great new app

  • III. Discuss how the Medical Device Data Systems

(MDDSs) Guidance makes dealing with medical device data easier

2

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SLIDE 3
  • I. Medical

Devices

  • I. Medical

Devices

  • II. MMAs
  • III. MDDSs

3

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SLIDE 4

W hat is a Medical Device?

4

According to Section 201(h) of the Food, Drug, and Cosmetics Act, a device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part,

  • r accessory which is:
  • 1. recognized in the official National Formulary, or the United States

Pharmacopoeia, 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
  • ther 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

  • f any of its primary intended purposes."
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SLIDE 5

W hat is a Medical Device?

5

According to Section 201(h) of the Food, Drug, and Cosmetics Act, a device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part,

  • r accessory which is:
  • 1. recognized in the official National Formulary, or the United States

Pharmacopoeia, 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
  • ther 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

  • f any of its primary intended purposes."

Devices can be pretty much anything, including hardware and software

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SLIDE 6

W hat is a Medical Device?

6

According to Section 201(h) of the Food, Drug, and Cosmetics Act, a device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part,

  • r accessory which is:
  • 1. recognized in the official National Formulary, or the United States

Pharmacopoeia, 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
  • ther 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

  • f any of its primary intended purposes."

This part doesn’ t really apply to software devices

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SLIDE 7

W hat is a Medical Device?

7

According to Section 201(h) of the Food, Drug, and Cosmetics Act, a device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part,

  • r accessory which is:
  • 1. recognized in the official National Formulary, or the United States

Pharmacopoeia, 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
  • ther 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

  • f any of its primary intended purposes."

Things are classified as a device based on their intended use

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SLIDE 8

W hat is a Medical Device?

8

According to Section 201(h) of the Food, Drug, and Cosmetics Act, a device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part,

  • r accessory which is:
  • 1. recognized in the official National Formulary, or the United States

Pharmacopoeia, 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
  • ther 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

  • f any of its primary intended purposes."

Devices affect are things that affect structure or function and aren’ t drugs

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Exam ple of How I ntended Use Affects Designation

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Exam ple of How I ntended Use Affects Designation

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Exam ple of How I ntended Use Affects Designation

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Exam ple of How I ntended Use Affects Designation

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Exam ple of How I ntended Use Affects Designation

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Medical devices:

  • diagnose
  • cure
  • mitigate
  • treat
  • prevent

disease*

  • I. Medical

Devices

  • II. MMAs
  • II. MMAs
  • III. MDDSs
  • I. Medical

Devices

Medical devices:

  • diagnose
  • cure
  • mitigate
  • treat
  • prevent

disease*

*: see S

ect ion201(h) of t he FD&C Act

14

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Mobile Medical Applications ( MMA) Guidance Docum ent

History:

  • MMA Guidance issued on September 25, 2013
  • MMA Guidance updated on February 9, 2015, to reflect Medical Device Data

Systems (MDDSs)

Provides:

  • Definitions
  • Regulatory Approach for MMAs
  • Summary of Regulatory Requirements for Medical Devices
  • Many Examples
  • FAQs

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Please see: “ Mobile Medical Applications - Guidance for Indust ry and Food and Drug Administ rat ion S t aff.”

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S

  • ftware

Mobile Apps Medical Devices

Using Venn Diagram s to get a sense of the Landscape

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Mobile Apps

T A

MMAs

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S

  • ftware

Mobile Apps Medical Devices

Using Venn Diagram s to get a sense of the Landscape

17

Mobile Apps

T A

MMAs

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Form al Definition of a Mobile Medical App ( MMA)

For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 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.

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Form al Definition of a Mobile Medical App ( MMA)

For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 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.

S

  • ftware that runs on a

mobile platform that…

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Form al Definition of a Mobile Medical App ( MMA)

For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 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.

Intended to:

  • diagnose,
  • cure,
  • mitigate,
  • treat, or
  • prevent
  • disease AND…

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Form al Definition of a Mobile Medical App ( MMA)

For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 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.

… something intended to be used with a regulated medical device…

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Form al Definition of a Mobile Medical App ( MMA)

For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 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.

… transforms the mobile platform INTO a regulated medical device.

22

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The focus of FDA ’s Regulatory Oversight

FDA’s Regulatory Approach

  • Regulatory approach is based on risk to patient safety

if the mobile app did not function as intended.

  • May help to think of placing a mobile application into
  • ne of three “buckets”:

Not a medical device

May be a medical device, but FDA intends to exercise enforcement discretion

Not a device Lower Risk Higher Risk

23

S

  • ft ware

Medical Devices Mobile Apps

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SLIDE 24

FDA’s Regulatory Approach

  • Regulatory approach is based on risk to patient safety

if the mobile app did not function as intended.

  • May help to think of placing a mobile application into
  • ne of three “buckets”:

MMAs

Not a device Lower Risk Higher Risk

24

S

  • ft ware

Medical Devices Mobile Apps

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S

  • ft ware

Medical Devices Mobile Apps

Not a device

Electronic Medical Textbooks and References Training Tools for Medical Education Office Automation in a Healthcare Setting Generic Aids or General Purpose Products

General Pat ient Educat ion and Facilit at e Access t o Common Reference

Exam ples of Mobile Apps that are NOT Medical Devices

Lower Risk Higher Risk

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Examples

  • First-aid or emergency care

information encyclopedias

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S

  • ft ware

Medical Devices Mobile Apps

Not a device

Electronic Medical Textbooks and References Training Tools for Medical Education Office Automation in a Healthcare Setting Generic Aids or General Purpose Products

General Pat ient Educat ion and Facilit at e Access t o Common Reference

Exam ples of Mobile Apps that are NOT Medical Devices

Lower Risk Higher Risk

26

Examples

  • Apps that simulate cardiac

arrest scenarios to train health professionals in advanced CPR

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SLIDE 27

S

  • ft ware

Medical Devices Mobile Apps

Not a device

Electronic Medical Textbooks and References Training Tools for Medical Education Office Automation in a Healthcare Setting Generic Aids or General Purpose Products

General Pat ient Educat ion and Facilit at e Access t o Common Reference

Exam ples of Mobile Apps that are NOT Medical Devices

Lower Risk Higher Risk

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Examples

  • Allow users to input pill shape,

color or imprint and display pictures and names of pills that match this description;

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S

  • ft ware

Medical Devices Mobile Apps

Not a device

Electronic Medical Textbooks and References Training Tools for Medical Education Office Automation in a Healthcare Setting Generic Aids or General Purpose Products

General Pat ient Educat ion and Facilit at e Access t o Common Reference

Exam ples of Mobile Apps that are NOT Medical Devices

Lower Risk Higher Risk

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Examples

  • Determine billing codes
  • Analyze insurance claims for

fraud or abuse

  • Generate reminders for

scheduled medical or blood donation appointments

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S

  • ft ware

Medical Devices Mobile Apps

Not a device

Electronic Medical Textbooks and References Training Tools for Medical Education Office Automation in a Healthcare Setting Generic Aids or General Purpose Products

General Pat ient Educat ion and Facilit at e Access t o Common Reference

Exam ples of Mobile Apps that are NOT Medical Devices

Lower Risk Higher Risk

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Examples

  • Allow health care providers to

communicate in a secure and protected method

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S

  • ft ware

Medical Devices Mobile Apps

Exam ples of Mobile Apps for w hich FDA I ntends to Exercise Enforcem ent Discretion

Patient Coaching

  • r

Prompting S imple Calculations Routinely Used in Clinical Practice Health Tracking Easy Access to Information Related to Patients’ Conditions

Help Patients Document, S how, or Communicate to Providers

Enable Interaction with PHR or EHR S ystems Apps that Meet Definition

  • f an MDDS

Not a device Lower Risk Higher Risk

30

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S

  • ft ware

Medical Devices Mobile Apps

Exam ples of Mobile Apps for w hich FDA I ntends to Exercise Enforcem ent Discretion

Patient Coaching

  • r

Prompting S imple Calculations Routinely Used in Clinical Practice Health Tracking Easy Access to Information Related to Patients’ Conditions

Help Patients Document, S how, or Communicate to Providers

Enable Interaction with PHR or EHR S ystems Apps that Meet Definition

  • f an MDDS

Not a device Lower Risk Higher Risk

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“ … for certain MMA devices… FDA intends not to pursue enforcement action for violations of the FD&C Act and applicable regulations… This does not constitute a change in the requirements of the FD&C Act

  • r any applicable regulation.”
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Subset of Mobile Apps that are the Focus

  • f FDA’s Regulatory Oversight ( MMAs)

Mobile Medical Apps Mobile Medical Apps

Control, Active Monitoring, & Analyze Medical Data Transform Mobile Platform into a Regulated Medical Device Patient-Specific Diagnosis or Treatment Recommendations

Not a device Lower Risk Higher Risk

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Mobile Medical Apps Mobile AND Medical AND (Accessory OR Transforms)

S

  • ft ware

Medical Devices Mobile Apps

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MMA Review

  • MMAs are Mobile AND Medical AND (Accessory OR Transforms)**
  • Medical Device: Intended use is a critical factor
  • Regulatory Approach: Based on risk to patient safety
  • MMA Guidance provides starting point for responsibilities of MMA

manufacturers.

  • More information about responsibilities for medical device

manufacturers can be found at “CDRH Learn” and “Device Advice”.

The focus of FDA ’s Regulatory Oversight

Not a medical device

May be a medical device, but FDA intends to exercise enforcement discretion

Not a device Lower Risk Higher Risk

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**: see MMAs Guidance Document

S

  • ft ware

Medical Devices Mobile Apps

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MMA Review

  • MMAs are Mobile AND Medical AND (Accessory OR Transforms)**
  • Medical Device: Intended use is a critical factor
  • Regulatory Approach: Based on risk to patient safety
  • MMA Guidance provides starting point for responsibilities of MMA

manufacturers.

  • More information about responsibilities for medical device

manufacturers can be found at “CDRH Learn” and “Device Advice”.

MMAs

Not a device Lower Risk Higher Risk

34

**: see MMAs Guidance Document

S

  • ft ware

Medical Devices Mobile Apps

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SLIDE 35
  • I. Medical

Devices

Medical devices:

  • diagnose
  • cure
  • mitigate
  • treat
  • prevent

disease*

  • III. MDDSs
  • II. MMAs
  • III. MDDSs
  • II. MMAs

MMAs are:

  • Mobile AND
  • Medical AND
  • (Accessory OR

Transforms)** MMAs are:

  • Mobile AND
  • Medical AND
  • (Accessory OR

Transforms)**

35

*: see S

ect ion201(h) of t he FD&C Act

**: see MMAs Guidance Document

S

  • ft ware

Medical Devices Mobile Apps

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SLIDE 36

So now you m ight be thinking…

  • How does FDA regulate the transfer, storage, conversion, and

display of data generated and/or collected by my app?

  • Medical Device Data Systems perform this set of features.

36

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How MDDSs are Regulated

Good News!

  • MDDSs were down-classified to Class I (low-risk) on

February 15, 2011.

  • MDDS Guidance issued on February 9, 2015, and

again placed under enforcement discretion.

37

Please see: “ Medical Device Dat a S yst ems, Medical Image S t orage Devices, and Medical Image Communicat ions Devices.”

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SLIDE 38

The Four Things MDDSs do w ith Medical Device Data

38

°C

kg </ xml>

°F

lbs. {j son}

Transfer Convert Formats S tore Display

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Definition of a Medical Device Data System ( MDDS)

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21 CFR 880.6310 Medical device data system (a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide

  • ne or more of the following uses, without controlling or altering the functions
  • r parameters
  • f any connected medical devices:

(i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from

  • ne format to another format in accordance with a preset

specification; or (iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

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SLIDE 40

Definition of a Medical Device Data System ( MDDS)

40

21 CFR 880.6310 Medical device data system (a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide

  • ne or more of the following uses, without controlling or altering the functions
  • r parameters
  • f any connected medical devices:

(i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from

  • ne format to another format in accordance with a preset

specification; or (iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring. MDDS s do NOT:

  • control functions or parameters
  • alter functions or parameters
  • f connected medical devices
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Definition of a Medical Device Data System ( MDDS)

41

21 CFR 880.6310 Medical device data system (a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide

  • ne or more of the following uses, without controlling or altering the functions
  • r parameters
  • f any connected medical devices:

(i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from

  • ne format to another format in accordance with a preset

specification; or (iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring. MDDS s DO:

  • transfer
  • store
  • convert
  • display

medical device data

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SLIDE 42

Definition of a Medical Device Data System ( MDDS)

42

21 CFR 880.6310 Medical device data system (a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide

  • ne or more of the following uses, without controlling or altering the functions
  • r parameters
  • f any connected medical devices:

(i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from

  • ne format to another format in accordance with a preset

specification; or (iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring. MDDS s include both hardware and software.

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Definition of a Medical Device Data System ( MDDS)

43

21 CFR 880.6310 Medical device data system (a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide

  • ne or more of the following uses, without controlling or altering the functions
  • r parameters
  • f any connected medical devices:

(i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from

  • ne format to another format in accordance with a preset

specification; or (iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring. MDDS s do NOT include devices for active patient monitoring

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MDDS Review

  • MDDSs are medical devices that:

 Transfer medical device data,  Store medical device data,  Display medical device data, or  Convert medical device data from one data format to

another format using a preset specification. But do NOT: Control functions of connected medical devices, Alter parameters of connected medical devices, Actively monitor patients.

  • MDDSs are Class I (low-risk) devices, and FDA does

not intend to enforce compliance with the regulatory controls.

44

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SLIDE 45
  • III. MDDSs

MDDS s:

 Transfer data  S

tore data

 convert data  display data

control alt er monitor***

  • III. MDDSs

MDDS s:

 transfer data  store data  convert data  display data

control alt er monitor***

  • I. Medical

Devices

  • II. MMAs

Medical devices:

  • diagnose
  • cure
  • mitigate
  • treat
  • prevent

disease*

*: see S

ect ion201(h) of t he FD&C Act

45

MMAs are:

  • Mobile AND
  • Medical AND
  • (Accessory OR

Transforms)**

**: see MMAs Guidance Document ***: see MDDS

Guidance Document

S

  • ft ware

Medical Devices Mobile Apps

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SLIDE 46

How to Get Help

CDRH Learn – Multimedia Industry Education:

  • http://www.fda.gov/Training/CDRHLearn/

Device Advice – Text-based Education:

  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

Digital Health Website:

  • http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

FDA Contact Information:

  • MobileMedicalApps@fda.hhs.gov
  • DICE@fda.hhs.gov

The Pre-Submission Program

  • http://www.fda.gov/downloads/medicaldevices/deviceregulationandgui

dance/guidancedocuments/ucm311176.pdf

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SLIDE 47

Questions?

47