After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a 50 percent overall reduction in improvement timelines, say FDA officials.

Speaking at the 18th Annual FDA Inspections vSummit, sponsored by FDAnews, a WCG company, officials acknowledged that the CAPA process has been cumbersome and focused too much on regulations and paperwork and not enough on true improvements and problem-solving.

“Companies liked to solve problems and make improvements but didn’t like the original CAPA process,” said Bleta Vuniqi, associate director of CDRH’s Office of Health Technology. “So, they just didn’t initiate improvement actions; they took the attitude instead that if it isn’t broken, we won’t try to fix it.”

To read the whole story, click here to subscribe.

Related Topics