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The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing. Read More
The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices Read More
The FDA and the Department of Homeland Security have flagged cybersecurity weaknesses in some St. Jude Medical implantable cardiac devices used with the company’s Merlin@home transmitters. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More