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A market research report on

Digital Therapeutics

Regulatory Process,

Updates & Trends

Digital Therapeutics - Overview DIGITAL HEALTH

DIGITAL MEDICINE

DIGITAL THERAPEUTICS

(DTx)

Technologies, platforms, and systems that Evidence-based hardware

Digital therapeutics (DTx)

engage users for lifestyle, wellness, and and/or software products that

products deliver evidence-based

health-related reasons, collect, store, or transmit Definition

monitor, treat, or otherwise

therapeutics interventions to

health data, and/or support life science and contribute to human health are

prevent, manage or treat a

clinical operations are all considered to be part of included in digital medicine

medical disorder or disease

the field of digital health

Clinical evidence and real world

Clinical

Clinical evidence is required for Typically do not require clinical evidence outcomes are required for all

Evidence

all digital medicine products

DTx products

Regulatory requirements may

DTx products needs to be

These products do not meet the regulatory vary. Digital medicine products

Regulatory

certified by regulatory bodies so definition of a medical device and do not require that are classified as medical

Oversight

as to support product claims of

regulatory oversight

device require clearance or

risk, efficacy and intended use

approval

Digital Therapeutics - Definition by FDA (US) Digital therapeutics are generally regulated as software by the FDA under the agency’s software-as-a-medical-device (SaMD) category and are subject to regulatory obligations much like conventional medical devices Summary

•

Development of a Software Precertification Program (Pre-Cert) aimed to replace the need for a premarket submission for certain products and allow for reduced submission content and/or faster review of the marketing submission

•

The FDA’s vision for the future is that companies taking advantage of the Pre-Cert program will also be able to utilize the National Evaluation System for health Technology (NEST) system

•

This aims to generate better evidence for medical device evaluation and regulatory decision making across the device lifecycle by collecting post-market, real-world data in order to affirm the regulatory status of the product and support new applications of the technology

•

Section 3060 of the Cures Act excludes from the definition of “device” software functions intended for activities such as healthcare facility administrative support, healthy lifestyle maintenance, or serving as electronic patient records, so long as the function is not intended to interpret or analyze them for the purpose of condition diagnosis, cure, mitigation or treatment 3

US FDA Medical Device Classifications for DTx FDA Medical Device Classification Class I - Low Risk

Class II – Medium Risk (40%)

Class III – High Risk (10%)

(Bandages, bedpans etc)

(Wheelchair, pregnancy kits etc)

(Pacemakers, breast implatns)

Premarket

Breakthrough

Humanitarian

Investigational

Company

Premarket

Notification

De Novo Program

Devices Program

Device Exemption

Registration

Approval (PMA)

(510(k))

(BDP)

(HDE)

(IDE)

95% of Class I

Demonstrate that

Novel device of

New combinations

New or similar

devices do not

device to be

low to moderate

of devices &

device for

device for clinical

Class III medical

require FDA

marketed is at

risk that don’t have

softwares

conditions that

studies to support

devices that

approval before

least as safe and

a valid predicate

affect less than

PMA

support or sustain

marketing the

effective –

device. May be

Priority review

8,000 US per year

life

device in US

equivalent to a

marketed & used

from FDA. A

Almost all Class III

legally marketed

as a predicates for

breakthrough

Meant to speed

devices are

device that is no

future 510(k)

technology with no

/incentive devices

required to

subject to PMA;

submissions

approved

targeting rare

complete an IDE

alternative or

diseases

application before

Software only

offers clinically

PMA unless

DTx (subsequent

DTx (first

meaningful

exempt

products)

advantages

US FDA Digital Therapeutics Initiatives Pilot Project by FDA

FDA Digital Health Innovation Future Action Plan Digital Health FDA Pre-certification

•

FDA launched the Software Precertification (Pre-Cert) Pilot Program ("the pilot") in 2017 to foster innovative technologies and advance FDA's mission to protect and FDA Pre-certification Level

promote public health

•

Pilot explored innovative approaches to regulatory Based on SaMD

SaMD Types

oversight of medical device software developed by Risk

Landscape/Sc

organizations that have demonstrated a robust culture of

ope

quality and organizational excellence and who are Pre-Cert Level

committed to monitoring real-world performance of their products once they reach the U.S. market Streamlined Premarket Review

•

In September 2022, the Software Precertification (Pre-Cert) Pilot Program was completed with the Commercial Distribution & Real World Use issuance of the Report: The Software Precertification (Pre-Cert) Pilot Program

Real-World Data Collection

Digital Therapeutics Regulatory Process in Germany Germany

•

Germany passed the Digital Care Act (‘Digitale Versorgung Gesetz’ or ‘DVG’) in 2019, it created a pathway for doctors to prescribe digital therapeutics to publicly-insured patients and receive reimbursement in much the same way as a traditional treatment

•

Germany’s Federal Institute for Drugs and Medical Devices ('BfArM') has issued guidelines relating to the evaluation process digital health apps (DiGAs) must go through to be eligible for reimbursement Regulatory Process

For any app to be eligible it must of the risk class I or IIa under the EU's Medical Device Directive (MDD) or, more importantly, the 1

incoming Medical Device Regulation (MDR) Most apps that self-classify as class I under MDD will be "up-classed" to class IIa under MDR, which means they'll have to adhere 2

to stricter requirements in order to acquire a CE mark BfArM's guidelines define further requirements for issues such as safety and efficacy, and the timeframe DiGA developers must 3

meet for their DTx to be approved Process has been dubbed the ‘Fast-Track’, as it allows DiGAs to be granted preliminary approval following an evaluation, after 4

which developers have 12 months to generate sufficient evidence for full approval 6

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