Digital Health Devices and Clinical Trials – Wearables Crash Course Webinar Series

© 2016 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com

Wearables in Clinical TrialsNAVIGATING THE UNCERTAINTY

June 14, 2016

© 2016 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com 2

This presentation has been provided for informational

purposes only and is not intended and should not be

construed to constitute legal advice. Please consult your

attorneys in connection with any fact-specific situation under

federal, state, and/or local laws that may impose additional

obligations on you and your company.

Cisco WebEx can be used to record webinars/briefings. By

participating in this webinar/briefing, you agree that your

communications may be monitored or recorded at any time

during the webinar/briefing.

Attorney Advertising

© 2016 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com

Presented by

Daniel G. Gottlieb

Associate

[email protected]

202-861-1881

3


FDA Regulation of Wearables

Risk-Based Approach

Mobile Medical App Guidance

FDASIA Report

MDDS Guidance

510(K) Exempt Devices Guidance

Wellness Draft Guidance

Accessory Draft Guidance

Clinical Decision Support

4

RegulatedWearables

Wearables subject toEnforcement

Discretion

Unregulated Wearables


What Wearables Can I Use in a Clinical Trial?

5

Any one you want, so long as the data collected are:


What Should I Be Thinking About?

What data are being collected?

How do I plan on using thesedata?

What am I going to use to collectthese data?

How am I going to get the datafrom the wearable to my clinicaltrial database?

How can I know the data beingcollected are from the subject?

General

HardwareSoftware

6



What data are being collected?

• Physical Measurements

• Patient Reported Outcomes

How do I plan on using thesedata?

• Primary Endpoints

• Adverse Events/subjectmonitoring

• Meta Analysis Only

• Clinical Decision Making

General

SoftwareHardware

7



What am I going to use to collectthese data?

• a regulated device

• a device subject to enforcementdiscretion

• an unregulated device

General

SoftwareHardware

8


Customer R&D

R&D with the IVD

Early

Basic Unapplied Applied

FDA-Regulated

Research intendedto generate data to

support asubmission

Use of IVD tosupport production

control

Research on IVD

RUO

Data used only forproduct

development

Not testing forsafety and

effectiveness

Not sharing resultswith caregivers or

subject

IUO

Clinical testinginvolving productMay be for safety

and/oreffectiveness

Can be forpremarket

submission butdoes not have to be

Human subjectprotection and 21CFR Part 812 apply

to use of device

Navigating the Hardware IssuesRuo as Guidance?

Obtainingfundamental

scientificknowledge

Evaluating IVDsability to solve aspecific problem

IVD would not be regulated but customerwould be required to demonstrate IVD is

reliable enough for the purpose of thestudy

9



How am I going to get the datafrom the wearable to my clinicaltrial database?

How can I know the data beingcollected are from the subject?

General

SoftwareHardware

10


Navigating the Software Issues

Applicable Regulations

• 21 CFR Part 11

• GCP Requirements

oRetention requirements 21 CFR 312.62(b) and 812.140(a)(3)

oAccessible at request of FDA pursuant to 21 CFR 312.62(c) and 812.140(d)

Helpful Guidance

• Guidance for Industry: Computerized Systems Used In Clinical Investigations (May2007)

• General Principles of Software Validation; Final Guidance for Industry and Staff(January 2002)

• Use of Electronic Health Record Data in Clinical Investigations; Guidance forIndustry (Draft May 2016)

11


How does it all fit together?

What is the intended use?

What data are you using?

How will the data be used?

What is the source of the data?

12


Questions?

Daniel G. Gottlieb

Associate

[email protected]

202-861-1881

13


FDA Cybersecurity Recommendations to Comply with NIST: A Best Practicefor All Wearables?June 21, 2016 at 2:00 – 2:15 p.m. ETKim Tyrrell-Knott

Privacy and WearablesJune 28, 2016 at 2:00 – 2:15 p.m. ETPatricia M. Wagner

To register, please visit: http://www.ebglaw.com/events/

Upcoming WebinarsWearables Crash Course Series

14

http://www.ebglaw.com/events/

Digital Health Devices and Clinical Trials – Wearables Crash Course Webinar Series

Law

Transcript of Digital Health Devices and Clinical Trials – Wearables Crash Course Webinar Series