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Navigating the Medical Device Regulations October 5, 2021

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (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

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