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Understanding the FDA's Draft Guidance on 510(k) Transfer of Premarket Notification and Key Recommendations

The Food and Drug Administration (FDA) has recently released a draft guidance document aimed at the healthcare and medical device...

4 days ago

Understanding the Critical Role of Clinical Evaluation in Medical Device Approval Processes

The world of medical devices is rapidly evolving, bringing about remarkable advancements in how we diagnose, treat, and manage patient...

Jun 6

Essential Best Practices for Effective Post-Market Surveillance in Medical Device Companies

Post-market surveillance (PMS) is crucial for the ongoing safety and effectiveness of medical devices after they hit the market. As...

Jun 6

Inside the FDA’s AI Shift: What Life Sciences Leaders Need to Know About Elsa

On June 4, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of Elsa , a new generative artificial intelligence (AI)...

Jun 4

Decoding the New UKCA Mark: Essential Insights for Medical Device Companies

In the wake of Brexit, the United Kingdom has created its own set of rules for different industries, including medical devices. The UK...

May 29

Navigating the Future of FDA 510k Submissions Through eSTAR Insights and Implications for Regulatory Leaders

n the fast-paced world of medical device regulation, keeping up with changes is crucial. One of the most significant shifts is the FDA's introduction of the electronic Submission Template and Resource (eSTAR) for 510(k) submissions. This move aims to make the submission process smoother, increase clarity, and ultimately improve patient access to safe medical devices. For regulatory operations and quality leaders in medical device companies, understanding eSTAR's details i

May 23

Navigating Common Pitfalls of EU MDR and How to Avoid them in 2025

The European Medical Device Regulation (EU MDR) continues to pose challenges for medical device manufacturers as they strive for compliance.

Apr 14

Which QMS Certification is Right for Your Company?

For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and market access.

Mar 17

Navigating the FDA's Latest Guidance on AI/ML in Medical Devices

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry by enabling adaptive, data-driven...

Mar 17

Avoiding FDA Inspection Findings: A Guide for Pharmaceutical and Biotech Companies

The pharmaceutical and biotech industries operate under intense regulatory scrutiny, with the U.S. Food and Drug Administration (FDA) ensuring compliance with Current Good Manufacturing Practices (cGMPs) and other regulatory requirements...

Feb 10

Donor Eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): FDA’s Evolving Guidance

The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) by regulating donor eligibility and screening protocols.