Update on software as a medical device (SaMD)

The TGA and IMDRF perspectives

David Hau
Medical Officer
Devices Clinical Section, Medical Devices Branch
Medical Devices and Product Quality Division, TGA
Digital Health Show 2017

30 March 2017
 Overview
1. What is a “Medical Device”?
– Definition and Regulation but not classification
2. Software as a Medical Device (SaMD)
– IMDRF working group update (NOT a regulation framework)
3. Pre and Post-market perspectives
– Issues and challenges of software Devices
4. Q&A
– Time permitting…

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Update on software a medical device (SaMD) - The TGA and IMDRF perspectives
Is it a “device”? Definition
41BD What is a medical device
(1) A medical device is:
(a) any instrument, apparatus, appliance, material or other article (whether used
alone or in combination, and including the software necessary for its proper
application) intended, by the person under whose name it is or is to be
supplied, to be used for human beings for the purpose of one or more of the
following:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii) diagnosis, ________, monitoring, treatment, alleviation of or compensation for an injury or
disability;
(iii) investigation, replacement or modification of the anatomy or of a physiological process;
(iv) control of conception;
and that does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but that may be assisted in its function by such means (cont…)
Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 2
Is it a “device”? Definition
41BD What is a medical device (cont.)

…and that does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but that may be assisted in its function by such means; or
(aa) any instrument, apparatus, appliance, material or other article specified under
subsection (2A); or
(ab) any instrument, apparatus, appliance, material or other article that is included in a class of
instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, material or other article covered by
paragraph (a), (aa) or (ab).

Note: Declarations under subsection (3) exclude articles from the scope of this definition. Declarations
under section 7 can also have this effect: see subsection 7(4).
Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 3
Is it a “device”? What’s the Intended Purpose?
41BD 2 Intended Purpose

• “Intended Purpose” is to be derived from labelling, instructions, advertising material and technical
documentation, provided by the Legal Manufacturer
– (the person under whose name the main equipment).
• NOTE:
– The Secretary may declare particular things, devices, classes, types,
or articles to be Medical Devices
… or NOT!
– Such a declaration under this section does not stop articles from being
therapeutic goods.
– Such a declaration takes effect on the day on which the declaration is
published – unless specified.
Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 4
Is it a “device”? Software becomes a device…
…when it meets the definition of what is a medical device.

That is, when the legal manufacturer intends*

for the software to be used in:
 diagnosis,
 prevention,
 monitoring,
 treatment, or
 alleviation, of disease

*The intention is ascertained from statements made by the

Manufacturer in labelling, instructions, advertising material or any
other documentation provided with or about the software.

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 5
Is all “medical software” regulated by TGA?
• NO (please see previous discussion)
• EXCLUSIONS may include:
– Software that is limited to managing and presenting information (HIS, dosage calculator)
– Software that are simply sources of information (like a textbook) or advice to health professionals or
consumers
 (except if it relates to the advertising of therapeutic goods, labelling, and instructions for use)

• INCLUDED likely includes

– Software that has a role in diagnosing or managing illness
– Software that analyses clinical data, such as the results of blood
tests or ECGs
• The TGA already regulates medical device software used for
therapeutic purposes under the medical devices regulatory framework.
Mobile apps would be considered within this framework.
Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 6
Is it regulated? Software regulated by TGA
• Software Used in Manufacturing Generally NOT Regulated:
• Software for maintaining QMS • No therapeutic purpose
• Software systems and toolsets • (not itself, nor part of, a device)
• Software with a therapeutic purpose • HIS, LIMS, PACS…
• Info storage and retrieval only with
– Firmware/embedded Software in
no “device” functions/features
 Monitors, Defibrillators, Pumps
 In vitro diagnostic devices
 Implantable (Pacemakers etc)
– Traditional Applications Possible room for doubt:
• Configuration/Setup Software
 Central Station on a PC
• Service Tools
– Standalone Software (on a disk only) • “Measurement” displays (graphs etc)
– Apps (from app store)

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 7
How is software regulated by TGA?
• The TGA regulates medical device software used for therapeutic
purposes under the medical devices regulatory framework (if they
meet the definition).
– Mobile apps would be considered within this framework
– Standalone Software would also be considered within this
framework
• Regulation is risk based, and depends on the intended purpose
• Manufacturers of medical device software products (other than
Class 1 - lowest risk) to obtain Conformity Assessment certification,
• All medical devices are expected to meet the Essential Principles for
safety and performance.
• For further information, please refer to Section 13 in Part 2 of
the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 8
Measuring functions – a point of contention
1.4 Medical devices with a measuring function
(1) For these Regulations, a medical device has a measuring function if the device is intended by the
manufacturer to measure:
(a) quantitatively a physiological or anatomical parameter; or
(b) a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the
human body.
(2) The measurements given by a medical device that has a measuring function:
(a) must:
(i) be displayed in Australian legal units of measurement or other units of measurement approved
by the Secretary for the particular device; or
(ii) be compared to at least one point of reference indicated in Australian legal units of
measurement or other units of measurement approved by the Secretary for the particular device;
and
(b) must be accurate to enable the device to achieve its intended purpose.
Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 9
Source: www.imdrf.org
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IMDRF – SaMD: several key achievements
• Definitions paper – what is SaMD
• Risks paper – framework for classifying risk
• Quality Management Systems (QMS) – translating QMS into SaMD
development
• Clinical Evidence - WIP

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 11
 High Catastrophic

IMDRF SaMD - Clinical

Type IV
Very
Impact

Type III Not

None Low Medium High

Not SaMD SaMD

Type II (Part of MD
i / Embedded
ii in MD)
Type I i
iii
i ii
iii
ii
i

Retrieves Optimizes Informs serious Informs critical Treat/ Diagnoses Treat/ Diagnoses Closed Loop
information Process non serious serious Interventions
No Clinical Intermediary
Organizes Data Informs Drives Drives serious Drives Treats/
non-serious non-serious critical diagnoses
critical
Functionality 12
Pre-market – Some general issues
• Evidence – having Adequate/appropriate
evidence regarding
– Performance
– Algorithms
– Design and Quality documentation
– Instructions

• Classification – accessory or device?

– Classification rules for devices

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 13
Post-market – some general issues
• Feature Creep - crossing the definitional line, • Feature obfuscation – deliberate “de-
one feature at a time emphasising” of features to down-classify
• E.g. a blood sugar level (BSL) tracking app: a device – practiced in USA
– Record BSL (rev 1.0) • Media and Public Interest – matching the
– Graph BSL (rev 1.3) promise to reality
– Trend BSL (rev 2.3) – Health market to reach $26 billion by
2017 (was just $700 million in 2011!)
– Alert BSL (rev 2.7)
• Blind to the Regs – not being aware of
building a regulated Medical Device
– Home tinkerers
– An “obvious” extension of an existing
product – remote view

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 14
Post-market incidents and complaints
• Learning to recognise reportable incidents • Capturing and tracking incidents and
is a big challenge – users may think… complaints – a big challenge
– Software issues are managed by a • Linking incidents to risk management –
“reboot” – so no report is needed… closing the feedback loop
wrong. • TGA’s Recognise, Retain, and Report
– Software issues are misidentified as campaign
“user issues” – no report needed…
wrong.
• Software issues most evident immediately
after an update/upgrade
• Upward trends (relating to quality) are
reportable

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 15
Post-market regulatory actions
Challenges Benefits
• Safety related updates under URPTG – • Software recalls - fixed “overnight” -
not widely known in Software industry everywhere, globally...
• Software expected to follow IEC 62304 – • Feedback in stores for possible complaint
recognised as state-of-the-art – linked to records
Essential Principles • Some ecosystems (e.g. Apple) can “force”
• Proliferation of “manufacturers” – with updates or disabling of features and apps
limited or no medical domain knowledge
• Software recalls - fixed by the time its
reported

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 16
Summary
• What is a “Medical Device”?
– Something that meets the definition in the Act
• Software as a Medical Device (SaMD)
– If it looks like a duck…
– IMDRF paper open for comment
• Post-market Perspectives
– Tracking and reporting incidents
– Updates aligned to correct regulatory pathway
• Q&A (Time permitting…)

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Update on software as a medical device (SaMD) - The TGA and IMDRF perspectives
Advice on software/apps regulation
The TGA web statement – worth a read:

• www.tga.gov.au/regulation-medical-software-and-mobile-medical-apps

Some highlights follow…

Other useful sources:

• FDA: Mobile Apps Guidance

www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

• IMDRF: SaMD – more on that shortly

www.imdrf.org/consultations/cons-samd-aqms-150326.asp

Update on software as a medical device (SaMD) - the TGA and IMDRF perspectives 18