In the wake of the pandemic, life sciences companies were challenged to pivot to adopt new technologies and rethink existing operating models to sustain growth and deliver innovation at speeds unseen in the industry. As a result of the evolution of technology in this sector, the Food and Drug Administration (FDA) has taken significant strides in 2023 to modernize the 510(k) program and evolve guidance to incorporate technological advancements. All 510(k) submissions, unless exempted, must be submitted electronically using their eSTAR platform, which went into effect October 1, 2023. The FDA published final guidance regarding cybersecurity measures and quality system consideration concerning medical devices specific to using the 510(k) pathway.

This edition covers:

+ 2023 Year in Review

+ Regulatory Updates

+ Key Coverages to Watch

+ Guidance