Warning Letter Policy Changes Here to Stay, Ulatowski Says

Devicemakers hoping to return to having 30 days to respond to Form 483 observations and prior attorney review of all warning letters are likely to be disappointed. The FDA has been reviewing both policy changes. Once the review process is complete, the policy changes will likely become permanent, Tim Ulatowski, director of CDRH’s Office of Compliance, said.
Devices & Diagnostics