www.raps.org
Open in
urlscan Pro
45.60.124.90
Public Scan
Submitted URL: https://app.marketing.outsetmedical.com/e/er?utm_campaign=providers_us_from_the_outset_july_2023&utm_content=providers_us_fto_july_2023_...
Effective URL: https://www.raps.org/news-and-articles/news-articles/2023/6/shuren-at-home-technologies-must-be-fit-for-purpos?utm_ca...
Submission: On July 20 via api from US — Scanned from DE
Effective URL: https://www.raps.org/news-and-articles/news-articles/2023/6/shuren-at-home-technologies-must-be-fit-for-purpos?utm_ca...
Submission: On July 20 via api from US — Scanned from DE
Form analysis 1 forms found in the DOM
<form>
<div class="form-group">
<div class="row">
<div class="col-md-12 text-center hide">
<p>Welcome to our new website! If this is the first time you are logging in on the new site, you will need to
<a href="https://my.raps.org/account/login.aspx?forgot=yes&RedirectUrl=https%3a%2f%2fwww.raps.org%2f&reload=timezone">reset your password</a>. Please contact us at <a href="mailto:raps@raps.org">raps@raps.org</a> if you need
assistance.</p>
</div>
<div class="col-sm-2"><label class="control-label"><svg class="icomoon icomoon-user">
<use xlink:href="#icomoon-user"></use>
</svg>Login</label></div>
<div class="col-sm-4 col-md-3"><label class="sr-only" for="loginUsername">E-mail address</label><input name="loginUsername" id="loginUsername" type="text" class="form-control" placeholder="E-mail address" autocomplete="on"></div>
<div class="col-sm-4 col-md-3"><label class="sr-only" for="loginPassword">Password</label><input name="loginPassword" type="password" id="loginPassword" class="form-control" placeholder="Password"></div>
<div class="col-sm-2"><input type="submit" class="loginBtn btn btn-default" value="Login"></div>
<div class="col-sm-12 col-md-2">
<ul class="list-unstyled login-help">
<li><a href="https://my.raps.org/account/login.aspx?forgot=yes&RedirectUrl=https%3a%2f%2fwww.raps.org%2f?reload=timezone" id="Header_ForgotPassword">Forgot Password?</a></li>
<li><a href="https://my.raps.org/account/login.aspx?signup=yes&RedirectUrl=https%3a%2f%2fwww.raps.org%2f" id="Header_CreateAccount">Create an Account</a></li>
</ul>
</div>
</div>
</div>
</form>Text Content
You need to enable JavaScript to run this app.
RAPS.org needs your explicit consent to store browser cookies. If you don't
allow cookies, you may not be able to use certain features of the web site such
as personalized content. Please see our Privacy Policy for more information.
Skip to Main NavigationSkip to Main ContentSkip to Footer
Close Search
Search:
Close Login
Welcome to our new website! If this is the first time you are logging in on the
new site, you will need to reset your password. Please contact us at
raps@raps.org if you need assistance.
Login
E-mail address
Password
* Forgot Password?
* Create an Account
* menu_open
Menu
* search
Search
* question_answer
Community
* school
Learning Portal
* calendar_today
Calendar
* shopping_bag
Marketplace
* storefront
Merchandise
* perm_contact_calendar
Open/Close Sign In
* Join
*
* News
* Membership
* Education
* Certification
* Resources
NEWS
News
Regulatory Focus
About RF
RF Quarterly
Subscribe
Press Room
Editorial Advisory Committee
Submission & Guidelines
Copyright & Terms
Advertise
MEMBERSHIP
Membership
Join
Renew
Student
Enterprise
Welcome to RAPS
Power of One
Directory
Chapters & Local Networks
Fellows
Get Involved
Regulatory Exchange (RegEx)
* MEMBER KNOWLEDGE CENTER
Your membership opens the door to free learning resources on demand. Check
out the Member Knowledge Center for free webcasts, publications and online
courses.
Get Started
EDUCATION
Education
Events
Books
Courses
Learning Portal
Corporate Training
Convergence
Euro Convergence
European Clinical and Risk Management Conference
Kellogg Executive Development
eCornell Leadership Certificate
* FUNDAMENTALS OF PHARMACEUTICAL AND BIOLOGICS REGULATIONS: A GLOBAL
PERSPECTIVE
Your one-stop resource for pharmaceutical and biologics regulations.
Buy the book
CERTIFICATION
Certification
My RAC
Apply
Prep Tools
Recertify
Exam Sites & Scheduling
About the RAC
RAC Holders
RAC Spotlights
* RAC SPOTLIGHTS
Hear from leaders around the globe as they share insights about their
experiences and lessons learned throughout their certification journey.
LEARN MORE
RESOURCES
Resources
Suppliers Guide
About the Profession
Careers
Competency Framework
Code of Ethics
Scope of Practice
Workforce Report
Success Partners
* Skip to Navigation
SHUREN: AT-HOME TECHNOLOGIES MUST BE FIT-FOR-PURPOSE
Regulatory News | 16 June 2023 | Ferdous Al-Faruque
CDRH Director Jeff Shuren has high hopes for at home medical technologies.
(Source: Ferdous Al-Faruque)
The head of the US Food and Drug Administration’s (FDA) device center believes
that moving medical technologies from the clinical setting into the home may
reduce costs and improve patient care; however, he cautioned that any medical
technology used at home must prove that it is fit-for-purpose.
Jeff Shuren, director of FDA’s Center for Devices and Radiological Health
(CDRH), spoke with Focus earlier this week about his vision for at-home medical
technologies.
Shuren recently said he wants to focus on helping get people preventative care
in their homes with the aid of digital health technology that allows for at-home
diagnosis, monitoring and treatment. (RELATED: Shuren: Getting QMSR out by
year’s end a ‘high priority’, Regulatory Focus 23 May 2023)
Following those comments, FDA published a list of questions for public feedback
on what the agency can do to encourage development of at-home technologies and
what factors should be considered when such technologies come to market.
“The reality is we're seeing a push for using technologies at home, and that's
in part to expand access and it's partly for reducing cost of care that
typically is going to occur in a clinical setting,” said Shuren. He added
healthcare institutions are increasingly using at-home technologies in areas
such as oncology and dialysis care. In some cases, technologies are being used
to support earlier patient discharge so that some of their care can be provided
at home.
The pandemic played a significant role in bringing more health technology into
the home, Shuren said, especially as people became more comfortable performing
at-home diagnostic tests.
“There already was a movement afoot prior to COVID, but it was accelerated with
the pandemic because people didn't have ready access to their providers and to
healthcare facilities, particularly earlier in the course of COVID, when you had
lockdowns,” said Shuren. “That's one of the reasons why we put in place a number
of flexible policies to facilitate modifications to devices to have digital
remote capabilities to help move care to the home or in some cases, even the
development of technologies without prior FDA review to be able to facilitate
care in the home, some of the adjunctive, behavioral therapies, for example.”
He also noted that at-home care can help achieve FDA’s strategic objective of
improving health equity by increasing access to care and lowering costs.
“One of the big drivers for increased costs is when it's provided within your
brick and mortar healthcare facility simply because those institutions providing
care are more expensive,” said Shuren. “If you're able to do that without the
need for all the people and facilities, you can help support cost savings.”
A key concern when asking patients to take care of themselves at home using the
technology available to them, is whether they can do so without the oversight of
healthcare professionals. While moving technologies from the clinical setting to
the home won’t change FDA’s safety and efficacy requirements, Shuren said,
sponsors need to think about the setting the technologies will be used in and
who will be using them.
“Any time you have a technology, you're always assuring it's fit-for-purpose for
the intended use in the intended users,” he said. “If you have technology that's
going to be available for use in the home, then it's got to be designed such
that consumers can use it safely.”
FDA often requires human factors testing especially when there is concern about
proper use of the product, and such testing may be required for at-home
technologies to show that patients are able to use the products safely and
effectively.
“That's pretty typical for technology in the home,” said Shuren. “Human factors
are even considered when devices are used by providers in some cases where there
may be issues around safety, or performance concerns when used inappropriately.”
“I don't think the fundamental considerations change because you always have to
think about safety and effectiveness in the context of the user that it is
fit-for-purpose, and here you're dealing with the lay user,” he added.
There is also concern that patients may not adhere to treatments as well at
home, compared to when they are being treated in clinical settings by healthcare
professionals. However, Shuren said he thinks there is greater opportunity to
ensure patients adhere to their treatments today, thanks to advances in
technology.
“It's one of the reasons why you see pharma companies very interested in digital
technologies to be able to better support adherence to administration of
medications,” he said. “Technology does provide that opportunity to further
support better adherence to treatments.”
That said, Shuren wants stakeholders to think about at-home technologies a bit
differently. He said at-home technologies are not going to be as effective if
they are “one-off technologies” and patients end up having to interact with
several technologies at once to manage their health.
“At the end of the day, people aren't going to tolerate having dozens of
technologies in the home for use in their care or wellness, it's just
overwhelming,” said Shuren. “Healthcare providers also can't handle that … It
becomes too much.”
Shuren urged developers to consider what the home setting should look like to
allow people to have to have certain interventions, diagnostics and screening
capabilities. He said those technologies should be baked into the home setting
or have plug-and-play capability so they are easy to use.
Shuren also noted the trend in consumer product companies expanding the use of
their products to include regulated health functions. Not only does this
movement have implications for moving treatment from the clinical setting to the
home, according to Shuren, it also has important implications for clinical trial
capabilities.
“If you kind of move to this idea of wellness prevention care in the home
setting, at the same time you should be thinking about the opportunities for
data collection and evidence generation, facilitating participation in clinical
studies,” said Shuren.
© 2023 Regulatory Affairs Professionals Society.
--------------------------------------------------------------------------------
Subscribe
DISCOVER MORE OF WHAT MATTERS TO YOU
BiologicsBiotechnologyClinical TrialsCombination
ProductsComplianceDiagnosticsMedical DevicesNorth
AmericaOtherPharmaceuticalsProduct LifecycleRegulatory
Intelligence/PolicyResearch, Design and Development
NEWS »
MDIC aims to encourage, fund advanced manufacturing with online clearing house
Recon: European industry group voice opposition to pharma overhaul; FDA approves
Sarepta’s DMD gene therapy for some children
See All Related News »
BOOKS »
Quality Management Systems for Drugs and Devices (e-book)
Risk Management Principles for Devices and Pharmaceuticals, Third Edition
See All Related Books »
LEARNING »
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD
Format (On-Demand)
REMS and RMPs [3.0 RAC]
See All Related Learning »
EVENTS »
China NMPA Regulations and Processes for Medical Devices (Nov 2023)
Sponsored Webcast: Delivering Higher Quality Products to Patients Faster Through
the Voluntary Improvement Program
See All Related Events »
VIEW FIGURE
← →
×
Close
Regulatory Affairs Professionals Society (RAPS)
5635 Fishers Lane, Suite 400
Rockville, Maryland 20852
P +1 301 770 2920 F +1 301 841 7956
Email: raps@raps.org
* ABOUT RAPS
* GOVERNANCE
* WORK FOR RAPS
* PRESS ROOM
* YEAR IN REVIEW
* CELEBRATE THE PROFESSION
* The Regulatory Profession
* RAPS In Europe
* Privacy Policy
* TERMS OF USE
* Advertise
* FAQ
* Code of Ethics
* CALL FOR AUTHORS
* Contact Us
* Facebook
* Instagram
* LinkedIn
* Twitter
* YouTube
© 2023
Regulatory Affairs Professionals Society
LockMembers
Onlyclosearrow-rightcartsearchgoogle-plusfacebooktwitteryoutubeflickrlinkedincalendarusermenumenu-closeprintsharecircle-downhelpbriefcaselatestreconstarword-bubblenews
×
We Value Your Privacy
Settings
NextRoll, Inc. ("NextRoll") and our advertising partners use cookies and similar
technologies on this site and use personal data (e.g., your IP address). If you
consent, the cookies, device identifiers, or other information can be stored or
accessed on your device for the purposes described below. You can click "Allow
All" or "Decline All" or click Settings above to customize your consent.
NextRoll and our advertising partners process personal data to: ● Store and/or
access information on a device; ● Create a personalized content profile; ●
Select personalised content; ● Personalized ads, ad measurement and audience
insights; ● Product development. For some of the purposes above, our advertising
partners: ● Use precise geolocation data. Some of our partners rely on their
legitimate business interests to process personal data. View our advertising
partners if you wish to provide or deny consent for specific partners, review
the purposes each partner believes they have a legitimate interest for, and
object to such processing.
If you select Decline All, you will still be able to view content on this site
and you will still receive advertising, but the advertising will not be tailored
for you. You may change your setting whenever you see the Manage consent
preferences on this site.
Decline All
Allow All
Manage consent preferences