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Category: US FDA
What Is Regulatory Affairs in Medical Devices: The Ultimate No Nonsense Guide
Introduction In the complex world of medical device development and commercialization, regulatory affairs plays a pivotal role in ensuring products are safe, effective, and compliant with global requirements. What is regulatory affairs in the medical device industry? At its core, regulatory affairs is the profession responsible for navigating the intricate web of regulations governing medical…
FDA eSTAR: Navigating the New Era of Medical Device Submissions
Introduction To The FDA eSTAR Program The medical device industry is witnessing a significant transformation in regulatory affairs, particularly in how manufacturers submit their applications to the US Food and Drug Administration (FDA). The Electronic Submission Template And Resource (eSTAR) program represents the FDA’s commitment to modernizing the review process for medical devices, moving away…