Consumer Diagnostics and Wellness Testing: Navigating the Medical Device Regulations – Webinar Recording/Transcript
Want to take advantage of the consumer diagnostics boom but you’re perplexed by changing regulatory, enforcement and policy issues?
One thing the pandemic proved: the public is increasingly reliant on widely deployable wellness, diagnosis and clinical decision support products and services, including those that don’t require a physician’s order.
With no signs of waning demand, companies are scrambling to get offerings to market. But if you can’t get a handle on the FDA’s enforcement approach, how can you succeed?
Example: Will some of the waivers granted by federal and state regulators during the pandemic be used as models for consumer diagnostics and wellness testing products more generally? Is this even wise?
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, so you can use it to your advantage to skillfully navigate this changing landscape.
- 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.
Meet Your Presenter
Mahnu Davar, a partner at Arnold and Porter, is trusted by lawyers, compliance officers, regulatory professionals and business executives across the life sciences industry. He counsels clients on mission-critical FDA, CLIA, fraud and abuse, and state licensing regulatory matters, including compliance program development and management. Mr. Davar routinely assists multinational companies with sensitive internal investigations, regulatory inspections, product quality and safety issues, data integrity concerns and government enforcement matters. He also assists clients in developing regulatory lifecycle strategies, particularly in the diagnostics and medical technology fields. Mr. Davar's clients include biotechnology startups, major clinical laboratories and some of the world's largest pharmaceutical and medical technology companies in oncology, ophthalmology and pain care. His practical, interdisciplinary approach to counseling is informed by prior secondments in the legal departments of major life sciences companies, where he has acted as the lead commercial lawyer for several blockbuster biopharma and surgical product franchises. Mr. Davar is an Adjunct Professor at Penn Law School, a Fellow of the Salzburg Seminar and a former Fulbright Scholar to India.
Who Will Benefit
- Software engineers
- Quality assurance/engineering professionals
- Regulatory affairs professionals
- Legal professionals
- Functional and business leaders
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Oct. 5, 2021