FDAnews Announces Consumer Diagnostics and Wellness Testing: Navigating the Medical Device Regulations October 5, 2021
Friday, October 8, 2021
Perplexed by next-gen regulatory, enforcement and policy issues in consumer diagnostics? Clarity on this fast-changing landscape is here.
FALLS CHURCH, Va., Sept. 30, 2021 /PRNewswire-PRWeb/ -- Consumer Diagnostics and Wellness Testing:
Navigating the Medical Device Regulations
An FDAnews Webinar
Tuesday, Oct. 5, 2021, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/consumer-diagnostics-and-wellness-testing
One thing the pandemic proved: the public is increasingly reliant on consumer diagnostics and wellness testing.
With no signs of waning demand, companies are scrambling to get offerings to market. The main challenge? What the regulatory, enforcement and policy future brings.
Mahnu Davar, a partner at Arnold and Porter in the life sciences and healthcare regulatory practice, will explain the next-generation enforcement approach in consumer diagnostics. Attendees will skillfully navigate this changing landscape when he shares:
-- The basics of FDA regulation of diagnostics products and components,
including FDA's enforcement discretion policy for lab-developed tests
-- How FDA applies medical device regulatory requirements to test kits and
component developments
-- The interaction between telehealth and prescription
diagnostics/diagnostic ordering regulations, including state medical
practice laws, the Clinical Laboratory Improvement Amendments (CLIA) and
FDA's regulation of prescription devices
-- How FDA enforces its requirements in this area and what liability
considerations you may face for noncompliance, including liability for
marketing unapproved/uncleared, adulterated or misbranded products
-- How the COVID-19 pandemic and its lessons learned may shape how
regulators will deal with issues involving consumer diagnostics going
forward
Clarity on forthcoming regulatory, enforcement and policy issues regarding consumer diagnostics is here. Don't miss out.
Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.
Webinar Details:
Consumer Diagnostics and Wellness Testing:
Navigating the Medical Device Regulations
An FDAnews Webinar
Tuesday, Oct. 5, 2021, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/consumer-diagnostics-and-wellness-testing
Tuition:
$297 per site
Easy Ways to Register:
Online: https://wcg.swoogo.com/consumer-diagnostics-and-wellness-testing
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations
Media Contact
Michelle Butler, FDAnews, 703.538.7600, mbutler@wcgclinical.com
SOURCE FDAnews
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