We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA finalized guidance on the evaluation process for De Novo classification requests and issued draft guidance on the acceptance criteria. Read More
Production workers at ATS Manufacturing threw out all of the nonconforming products they found and failed to document any follow-up activities over the course of nearly four years, an FDA investigator discovered in an August 14-18 inspection. Read More