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Developing classification guidance for IVDs, and industry guidelines for assigning unique device identifies are some of the actions categorized as high priorities. Read More
As the EU implements its new medical device and IVD regulations, the association is urging the UK to remain aligned with the EU27 regulatory system. Read More
No training was provided to the executive assistant who had been conducting quality audits at the firm’s manufacturing facility, an FDA investigator said. Read More
Earlier this year, representatives of 36 conservative groups sent a letter to Congress urging lawmakers to block the return of the device tax on Jan. 1. Read More
Moving into 2018, CDRH is focused on two main objectives to change how inspections of medical device manufacturing facilities are conducted — the case for quality and program alignment. Read More