Medical Device & IVD Regulatory | SCIENCE ARENA

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FDA Regulatory Pathways for LNP(Lipid Nano Particle)-Based mRNA Therapeutics: Fast Track to Approval

bySCIENCE ARENA -April 11, 2025

Messenger RNA (mRNA)-based therapeutics have ushered in a new era of precision medicine. These t…

FDA Evaluates Contaminants, Including Metals, in Tampons Through Independent Literature Review

bySCIENCE ARENA -December 24, 2024

The U.S. Food and Drug Administration (FDA) has released findings from an independent review of …

FDA Medical Device Classification: A Guide to US FDA 😷Administration

bySCIENCE ARENA -December 08, 2024

Medical devices are integral to modern healthcare, ranging from simple tools like bandages to ad…

Guidance on De Novo Classification Requests

bySCIENCE ARENA -July 21, 2024

A De Novo classification request provides a marketing pathway for novel medical devices for whic…

Pre-Market Approval | Industry Guidance

bySCIENCE ARENA -April 08, 2024

A PMA (Pre-Market Approval) Class III medical device represents the FDA's most stringent reg…

Medical Device Single Audit Program (MDSAP)

bySCIENCE ARENA -March 28, 2024

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to a…

Understanding the Quality System Regulation (QSR) for Medical Devices and IVDs

bySCIENCE ARENA -March 21, 2024

The Quality System Regulation (QSR) , outlined in Title 21 of the Code of Federal Regulations (2…

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