FDA Compliance

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AI Guidance for Medical Devices | NAMSA

Published: April 3, 2023

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U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

Published: February 8, 2023

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Health Canada and FDA eSTAR Pilot

Published: January 18, 2023

ISO 10993-18 Primer: Medical Device Chemical Characterization

Published: October 31, 2022

Why Complete Chemical Characterization Matters for Plastics

Published: October 18, 2022

Understanding the Complex Combination Product Pathway

Published: October 18, 2022

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FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software

Published: September 30, 2022

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Digital Health Software Pre-Certification Update: Final FDA Report Revealed

Published: September 28, 2022

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Navigating the 510(k) EO Sterility Change Master File Program

Published: June 29, 2022

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Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry

Published: May 16, 2022

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FDA Announces Optional Pathway for Clearance of Surgical Sutures

Published: April 13, 2022

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FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Published: April 12, 2022

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Industry Update: U.S. FDA Quality Management System Regulation

Published: February 28, 2022

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ACS Releases Review of Chemical Characterization Practices for Medical Devices on Behalf of FDA

Published: February 23, 2022

Overcoming Obstacles to Tissue Sterilization Validation: What Manufacturers Need to Know

Published: February 21, 2022

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FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”

Published: January 31, 2022

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