Experts: Recalls, Timelines Biggest Issues for Industry
With the agency increasing its enforcement activity and generally giving companies 15 days to respond to a Form 483 before issuing a warning letter, the likelihood of mistakes being made in response documents is increasing, Casper Uldriks, associate director for Regulatory Guidance and Government Affairs at the Center for Devices and Radiological Health, said at the fourth annual Medical Device Regulatory, Reimbursement and Compliance Congress last month.
Allegations have cropped up that the FDA is requiring manufacturers to recall older models of devices when they introduce improved
versions — even
though there are no safety issues or complaints about the older devices.
The GMP Letter