Wearable wellness products. Mobile apps. 3D printing. OTC genetic tests. LDTs. Combination products.
FDA Commissioner Scott Gottlieb has stated that he intends to modernize the FDA’s traditional approach to regulation to ensure that policies are suited to the novel challenges presented by new technology.
What are these initiatives — and how will they affect your regulatory strategy?
It’s time to find out what is OK (and not OK!) to do today … tomorrow … and in the weeks and months to follow.
FDAnews has called on a top medical device regulation experts, Suzan Onel and Will Woodlee, partners at Kleinfeld, Kaplan & Becker LLP, to guide you through the regulatory, quality and legal maze. It’s a day packed full of panel discussions on topics from emerging policies to strategies for working with the FDA. And there’s no need to travel — the whole event is livestreamed for your convenience.
You’ll end the day fully briefed on how to comport yourself in the current regulatory climate … and prepare for what lies down the road.
Here’s just a sampling of what the event will cover:
- Emerging FDA policies — wearable wellness products, 3D printing, OTC genetic tests, lab developed tests (LDTs), and combination products
- Current trends in enforcement
- The requirements for disclosure of medical device clinical trial information on ClinicalTrials.gov
- How the FDA’s regulations on the use of OUS data in premarket submissions have changed
- How the reorganization of CDRH, ORA, and ODE could affect the development and approval of medical devices
- Legislative initiatives that may impact medical devices
- Strategies for interacting with FDA and managing risk
- Real world, practical insight on making premarket submission decisions and whether to prepare a Letter to File (LTF) or file a 510(k), De Novo, or PMA submission.
- And much more
Stay abreast of emerging trends and developments in the dynamic world of innovative medical devices. This groundbreaking livestream event provides an overview of recent regulatory, compliance, policy, and legislative developments and offers practical insight into regulatory and quality issues.