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.
Who Will Benefit:
- Software engineers
- Quality assurance/engineering professionals
- Regulatory affairs professionals
- Legal professionals
- Functional and business leaders