FDA Forecast 2024: What Device and Diagnostics Regulatory Professionals can Expect from FDA Next Year

Description: With the start of the new fiscal year just days before the RAPS Convergence, regulatory professionals working in the medical device and diagnostics industries are wondering what the regulatory year ahead looks like for the FDA – and industry. In this 60-minute, fast-paced and lively session, leading regulatory intelligence professionals will present our evidence-based predictions on what we think FDA will be focused on most in the coming fiscal year, with a focus on medical devices, digital health products, and diagnostics.

This popular session, typically presented as an annual RAPS webcast to hundreds of participants, will benefit from a practical approach. Presenters will offer a data- and facts-driven presentation looking at:

- Things we know: The guidance, regulations, pilot programs and reports that FDA is required to publish under legislation and the user fee reauthorization, and what industry should look out for;
- Ongoing challenges: Things we know the FDA will struggle with (or continue to struggle with) and what those challenges mean for industry; and
- Potential wildcards: Low-probability, high-impact events that could cause major problems for the FDA and industry.

Session attendees will take away from this session an advanced understanding of the trends, milestones, decision-points and challenges that are most likely to affect their companies in 2024 and beyond. Attendees will come away better prepared to plan their regulatory strategies and ensure their companies are prepared for catalyst events and opportunities.