Resources

This presentation will explore the intersection of Artificial Intelligence (AI) in medical devices and the FDA’s 510(k) premarket notification process. It will highlight and address the challenges posed by the...

Connected devices often feature complex system architectures with multiple components and subsystems, frequently developed by different teams. This session will highlight common pitfalls encountered during the development of connected devices—issues...

So you think you’ve got a connected medical device? Medical Device Regulators do not approve good ideas, they approve fully developed medical devices. This means that a working prototype and...

In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies....

In the highly regulated pharmaceutical industry, compliance with FDA regulations is paramount to ensuring product safety and overall quality. When a large pharmaceutical company received a Form FDA 483 and...

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR...