registration of software - gakeslabindonesia.id · 2 amdc meeting surabaya indonesia oct 2017...

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AMDC Meeting Surabaya Indonesia Oct 2017

Alfred KWEK

ASEAN Medical Device Committee Meeting

Back to Back Industry Training

October 2017

Registration of Software

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Outline of Presentation

• Different Forms of Software

– Software in a Medical Device

– Software as a Medical Device (SaMD)• Mobile Medical App (as an example; not exhaustive)

• Historical Development of Mobile App

• Regulation of Mobile Medical App

– USFDA

– EU

• Conclusion

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AHWP: 3 Broad Categories of Medical Device Software

(A) Software that drives a medical device or influences the use of

a device. This typically refers to Software in a Medical Device or

embedded software, which is incorporated as a component or part

of accessory of a medical device.

• E.g. imaging software in diagnostic ultrasound system, software in

pacemaker, mobile software that controls insulin pump delivery rate

AHWP WG3: Guidance document on Medical Device Software – Qualification and Classification

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(B) Software that is intended to be an accessory to a medical

device

• E.g. Software that accepts data transmitted from medical devices

(C) Software that is a medical device in its own right

• Software related to the functioning of a medical device may be part

of a device or a device in its own right if it is placed on the market

separately from the related device.

• E.g. Treatment planning software, data analysis software for the

purpose of directly aiding in the treatment or diagnosis of a patient


AHWP: 3 Broad Categories of Medical Device Software

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AHWP Definition of Software in a Medical Device

A software application that is embedded in or is a part of

dedicated hardware medical devices and achieves its

intended medical purpose together with the hardware

medical device.

• is used as an accessory to a regulated medical

device; or

• transforms a mobile platform into a regulated medical

device.


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AHWP Definition of SaMD

Definition: SaMD is defined as software intended to be used for one or

more medical purposes that perform these purposes without being part

of a hardware medical device.

NOTES:

a. SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.

b. SaMD is capable of running on general purpose (non-medical purpose) computing

platforms.

c. “without being part of” means software not necessary for a hardware medical device

to achieve its intended medical purpose.

d. Software does not meet the definition of SaMD if its intended purpose is to drive a

hardware medical device.

e. SaMD may be used in combination (e.g., as a module) with other products including

medical devices.

f. SaMD may be interfaced with other medical devices, including hardware medical

devices and other SaMD software, as well as general purpose software.

g. Mobile apps that meet the definition above are considered SaMD.


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Defining the Medical Purpose

1. Satisfy Definition of a Medical Device

2. Satisfy Definition of an IVD

3. Additional considerations for SaMD

SaMD may also:

• provide means and suggestions for mitigation of a disease;

• provide information for determining compatibility, detecting,

diagnosing, monitoring or treating physiological conditions, states of

health, illnesses or congenital deformities;

• be an aid to diagnosis, screening, monitoring, determination of

predisposition; prognosis, prediction, determination of physiological

status.

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf

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1991 Fad

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USA RadioShack

1991

Advertisement

1. Stereo2. Clock3. Radio4. Phone5. Calculator6. PC7. Cellular Phone8. CD Player9. Phone Answerer10. Camcorder11. Speed Dial12. Tape Recorder

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2013 / 4 Fad

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New device diagnoses sick people using a mobile phone and cloud

Costing only US$25, the universal

Mobile Electrochemical Detector,

or uMED, can perform chemical a

nd biochemical tests on a variety

of commercially available test strip

s and electrodes and send the res

ults over an audio cable connecte

d to the headphone jack of any cel

l phone – even if it isn’t a smartph

one.

After placing a phone call, the use

r can upload the data over the voi

ce channel of any mobile network

(2G, 3G, or 4G) that is present on

site. There is no need for an intern

et connection.

http://theconversation.com/new-device-diagnoses-sick-people-using-a-mobile-phone-and-the-cloud-29460 (Accessed 6 Aug ‘14)

http://theconversation.com/new-device-diagnoses-sick-people-using-a-mobile-phone-and-the-cloud-29460

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http://appleinsider.com/articles/14/01/31/apple-execs-met-with-head-of-fda-to-discuss-mobile-medical-applications

Environment: Mobile Medical Apps

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http://www.bloomberg.com/news/2014-01-10/google-x-staff-meet-with-fda-pointing-toward-new-device.html

Possible Trends: Smart Wearable Devices

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http://in.news.yahoo.com/apple-meets-fda-rumoured-39-healthbook-39-ios-084133465.html

Possible Trends: “MyOwn” Medical Records

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2017 Fad

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https://www.cnbc.com/2017/09/27/fda-helps-apple-alphabet-and-samsung-in-long-term-health-care-bets.html Accessed 1 Oct 2017

https://www.cnbc.com/2017/09/27/fda-helps-apple-alphabet-and-samsung-in-long-term-health-care-bets.html

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iOS 11 (latest as of Oct 2017)

https://www.apple.com/sg/ios/health/ Accessed 2 Oct 2017

https://www.apple.com/sg/ios/health/

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Digitization Across Health Care Continuum

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Rapid Evolving Situation

https://www.fda.gov/MedicalDevices/DigitalHealth/ucm570617.htm Accessed 1 Oct 2017

https://www.fda.gov/MedicalDevices/DigitalHealth/ucm570617.htm

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FDA Regulation of MMA

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US FDA Guidance: Sep 2013

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US FDA Guidance: Feb 2015

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FDA Guidance - What Is Mobile Medical Apps: Definitions

Mobile Application (Mobile App)

A mobile application or “mobile app” is defined as a software application that can be executed (run) on

a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without

wireless connectivity), or a web-based software application that is tailored to a mobile platform but is

executed on a server.

Mobile Medical Application (Mobile Medical App)

“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)4; 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.

The FDA has previously clarified that when stand-alone software is used to analyze medical device

data, it has traditionally been regulated as an accessory to a medical device or as medical device

software.

Why? Interpretation of radiological images on a mobile device could be adversely affected by the

smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform. FDA

intends to take these risks into account in assessing the appropriate regulatory oversight for these

products.

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What & When is A Function a Medical Device?

Example: a mobile app that makes a light emitting diode (LED) operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific medical device intended use), the mobile app would not be considered a medical device.

If, however, through marketing, labelling, and the circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for use as a light source for doctors to examine patients, then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.

Based on FDA Guidance: “transform a mobile platform into a regulated medical device.”

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What & When is A Function a Medical Device?

Mobile medical apps intended to run on smart phones to analyze

and interpret ECG waveforms to detect heart function irregularities

would be considered similar to software running on a desktop

computer that serves the same function, which is regulated under

21 CFR 870.2340 (“Electrocardiograph”).

FDA’s oversight approach to mobile apps is focused on their

functionality, just as FDA focus on the functionality of conventional

devices.

Oversight is not determined by the platform.

FDA would not regulate the sale or general/conventional consumer

use of smartphones or tablets.

FDA’s oversight applies to mobile apps performing medical

device functions, such as when a mobile medical app transforms a

mobile platform into a medical device.

Oversight authority only to those mobile apps whose functionality

could pose a risk to a patient’s safety if the mobile app were to

not function as intended.

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Examples of MMAsMobile apps that transform a mobile platform into a regulated medical device and therefore are

mobile medical apps:

• These mobile apps use a mobile platform’s built-in features such as light, vibrations, camera, or other similar

sources to perform medical device functions (e.g., mobile medical apps that are used by a licensed practitioner

to diagnose or treat a disease). Possible product codes: Varies depending on the intended use and function of

the mobile medical app; see additional examples below.

• Mobile apps that use a sensor or lead that is connected to a mobile platform to measure and display the

electrical signal produced by the heart (electrocardiograph or ECG). Possible product code(s): DPS, MLC,

OEY (21 CFR 870.2340), MLO, MWJ (21 CFR 870.2800).

• Mobile apps that use a sensor or electrode attached to the mobile platform or tools within the mobile platform

itself (e.g., microphone and speaker) to electronically amplify and “project sounds associated with the heart,

arteries and veins and other internal organs” (i.e., an electronic stethoscope). Possible product code: DQD (21

CFR 870.1875(b)).

• Mobile apps that use a sensor or electrode attached to the mobile platform or tools within the mobile platform

itself (e.g., accelerometer) to measure physiological parameters during cardiopulmonary resuscitation (CPR)

and give feedback about the quality of CPR being delivered. Possible product code: LIX (21 CFR 870.5200).

• Mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself to

record, view, or analyze eye movements for use in the diagnosis of balance disorders (i.e.,

nystagmograph). Possible product code: GWN (21 CFR 882.1460).

• Mobile apps that use tools within the mobile platform (e.g., speaker) to produce controlled levels of test tones

and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of

possible otologic disorders (i.e., an audiometer). Possible product code: EWO (21 CFR 874.1050).

• Mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself (e.g.,

accelerometer) to measure the degree of tremor caused by certain diseases (i.e., a tremor transducer).

Possible product code: GYD (21 CFR 882.1950).

https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368743.htm Accessed 1 Oct 2017

https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368743.htm

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Examples of MMAs

Mobile apps that transform a mobile platform into a regulated medical device and therefore are

mobile medical apps:

• Mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself

(e.g., accelerometer, microphone) to measure physiological parameters (e.g., limb movement, electrical

activity of the brain (EEG)) during sleep and are intended for use in diagnosis of specific diseases or

conditions such as sleep apnea. Possible product code(s): OLV (21 CFR 882.1400), LEL, MNR (21 CFR

868.2375), FLS, NPF (21 CFR 868.2377).

• Mobile apps that use an attachment to the mobile platform to measure blood oxygen saturation for

diagnosis of specific disease or condition. Possible product code(s): DQA, NLF, MUD, NMD (21 CFR

870.2700) or DPZ (21 CFR 870.2710).

• Mobile apps that present donor history questions to a potential blood donor and record and/or transmit

the responses to those questions for a blood collection facility to use in determining blood donor eligibility

prior to collection of blood or blood components. Possible product code: MMH

• Mobile apps that use an attachment to the mobile platform to measure blood glucose levels. Possible

product code: NBW (21 CFR 862.1345).

• Mobile apps that use that use an attachment to the mobile platform (e.g., light source, laser) to treat

acne, reduce wrinkles, or remove hair. Possible product code: OLP, OHT, OHS (21 CFR 878.4810),

OZC (21 CFR 890.5740).

• Mobile apps that use a microphone or speaker within a mobile platform to serve as a audiometer to allow

healthcare providers to determine hearing loss at different frequencies. Possible product code: EWO (21

CFR 874.1050) [Added March 12, 2014]

• Mobile apps that analyze an image of a skin lesion using mathematical algorithms, such as fractal

analysis, and provide the user with an assessment of the risk of the lesion. [Added March 12, 2014]



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Examples of MMAs

Mobile apps that connect to an existing device type for purposes of controlling its operation,

function, or energy source and therefore are mobile medical apps:

• These mobile apps are those that control the operation or function (e.g., changes settings) of an

implantable or body worn medical device. Possible product codes: Varies depending on the

intended use and function of the parent medical device; see additional examples below.

• Mobile apps that alter the function or settings of an infusion pump. Possible product codes:

MEB, FRN, LZH, LZG, OPP, MEA (21 CFR 880.5725), FIH (21 CFR 876.5820), LKK.

• Mobile apps that act as wireless remote controls or synchronization devices for computed

tomography (CT) or X-Ray machines. Possible product code: JAK (21 CFR 892.1750), IZL (21

CFR 892.1720), KPR (21 CFR 892.1680).

• Mobile apps that control or change settings of an implantable neuromuscular

stimulator. Possible product code(s): GZC (21 CFR 882.5860).

• Mobile apps that calibrate, control, or change settings of a cochlear implant. Possible product

code(s): MCM.

• Mobile apps that control the inflation or deflation of a blood-pressure cuff. Possible product

code: DSJ (21 CFR 870.1100), DSK (21 CFR 870.1110), DXN (21 CFR 870.1130).

• Mobile apps that are used to calibrate hearing aids and assess the electroacoustic frequency

and sound intensity characteristics emanating from a hearing aid, master hearing aid, group

hearing aid or group auditory trainer. Possible product code ETW (21 CFR 874.3310) [Added

March 12, 2014].



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Examples of MMAs

• Mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device and therefore are mobile medical apps:

• Mobile apps that connect to a nursing central station and display medical device data to a physician’s mobile platform for review. (i.e., a medical device data system or MDDS). Product code: OUG (21 CFR 880.6310).

• Mobile apps that connect to bedside (or cardiac) monitors and transfer the data to a central viewing station for display and active patient monitoring. Possible product code(s): DSI, MHX, MLD (21 CFR 870.1025), DRT, MWI, MSX (21 CFR 870.2300).

• Mobile apps that connect to a perinatal monitoring system and transfer uterine contraction and fetal heart rate data to another display to allow for remote monitoring of labor progress. Possible product code(s): HGM (21 CFR 884.2740).

• Mobile apps that are intended to display images for diagnostic review may be regulated as a picture archiving and communications system. Possible product code LLZ, (21 CFR 892.2050) [Added March 12, 2014].

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Examples of FDA 510k that includes MMA (220 premarket clearances)

https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161302.pdf Accessed 1 Oct 2017http://www.edan.com.cn/html/EN/products/ECG/Resting/201404/251588.html

iPad-Based ECG work station

https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161302.pdf

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Regulation of Mobile Devices and App Store

Does the FDA regulate mobile devices and mobile app stores?

• FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets.

• FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.

• FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.



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21st Century Cures Act (Dec 13, 2016)

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21st Century Cures Act (Dec 13, 2016)

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EU Conformity Assessment

for MMA

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EU MedDev Guidance 2.1/6

Figure 1: A Decision Diagram to assist qualification

of Software as medical device

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EU MedDev 2.1/6 Guidance

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EU MedDev 2.1/6 Guidance: Page 10

Decision 3 asks the question

Is the software performing an action on data different from ( meaning more than) storage, archival, lossless compression, communication or simple search.

The key word here is storage and so we must consider whether this App does more than store or archive the data input from the individual.

The comments on page 10 acknowledge that embellishment* of the data does not imply performing an action.

An App that only stores data input by the individual and does not manipulate this data or perform any calculation and so when viewed it only shows the data input by the individual, effectively reminding him what he already knew.

* Embellishment means a decorative detail or feature added to something to make it more attractive.

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Increase in Mobile Medical App

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Interpretation of FDA Guidance Document

Regulated Medical Mobile Apps

/ AccessoriesNo Regulation as a Medical Device

No Regulation (Subject to

Conditions)

Heart Rate Monitor for General Wel

l Being; Not a medical device and c

annot be used for diagnosis of a dis

ease

AliveCor: FDA cleared 510K number K130409. Intended for use by licensed medical professionals or patients to record, display, store and transfer single channel ECG rhythms. Prescription Use only.

Clear + targeted + differentiated regulation for different products

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Defining the Medical Purpose

1. Satisfy Definition of a Medical Device

2. Satisfy Definition of an IVD

3. Additional considerations for SaMD

SaMD may also:

• provide means and suggestions for mitigation of a disease;

• provide information for determining compatibility, detecting,

diagnosing, monitoring or treating physiological conditions, states of

health, illnesses or congenital deformities;

• be an aid to diagnosis, screening, monitoring, determination of

predisposition; prognosis, prediction, determination of physiological

status.

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf

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SaMD Definition Statement

A. Significance of the information provided by the SaMD to the

healthcare decision

treat or diagnose,

drive clinical management,

inform clinical management;

Description of the core functionality of the software (e.g. Identify and prompt

healthcare providers of potential arrhythmia episodes in cardiac patients based on

their ECG recording).

A. State of the healthcare situation or condition

critical situation or condition

serious situation or condition

non-serious condition

WG3: Guidance document on Risk Classification of SaMD Final

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SaMD does not limit the supply through:

• Physical Delivery of Removable Media (e.g. DVD, USB Flash Drive

etc.)

• Download, transfer and/or installation directly to the end-user, and

may be used as an accessory to a regulated medical device, or

transform a general purpose platform (e.g. mobile platform) into a

regulated medical device

• Web/Cloud-based software which is executed on a remote server

through a web browser or mobile platform. A web-based software

would involve the delivery of the Software as a service rather than a

product.

WG3: Guidance document on Medical Device Software – Qualification and Classification

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MMA Concerns

Mobile Medical Apps & Accessories: Concerns

Familiar with traditional hospital based medical devices for treatment and diagnostic purposes. New and

innovative technology such as lifestyle heart rate monitor, lifestyle stress app, data storage, lifestyle

lethargy, are not familiar to media and public.

How to Manage Concerns (Public / Media)?

Should differentiate: Lifestyle based MMA, accessories and mobile phones have no clinical purposes.

Controls should be on prohibiting misleading claims.

Hospital Use

HRM

Clear cut medical

device. Regulate!

Lifestyle MMA &

Accessories

Manage Concerns: Product Claims + Labelling + Presentation of Product

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ASEAN Medical Device Committee Meeting

Back to Back Industry Training

October 2017

Thank You

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`Medical device', means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by the manufacturer to be used, alone or in combination, for humans for one or more of the specific purpose(s) of:

· diagnosis, prevention, monitoring, treatment or alleviation of any disease,· diagnosis, monitoring, treatment, alleviation of or compensation for an injury,· investigation, replacement, modification, or support of the anatomy or of a physiologicalprocess,

· supporting or sustaining life,· control of conception,· disinfection of medical devices,· providing information for medical or diagnostic purposes by means of in vitroexamination of specimens derived from the human body;

and

which does not achieve its primary intended action in or on the human body by pharmacological,immunological or metabolic means, but which may be assisted in its intended function by such means.

Definition of Medical Device

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`Medical device', means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by the manufacturer to be used, alone or in combination, for humans for one or more of the specific purpose(s) of:

· diagnosis, prevention, monitoring, treatment or alleviation of any disease,· diagnosis, monitoring, treatment, alleviation of or compensation for an injury,· investigation, replacement, modification, or support of the anatomy or of a physiologicalprocess,

· supporting or sustaining life,· control of conception,· disinfection of medical devices,· providing information for medical or diagnostic purposes by means of in vitroexamination of specimens derived from the human body;

and

which does not achieve its primary intended action in or on the human body by pharmacological,immunological or metabolic means, but which may be assisted in its intended function by such means.

Definition of Medical Device

registration of software - gakeslabindonesia.id · 2 amdc meeting surabaya indonesia oct 2017...

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