Aware that issuance and closure of devicemaker warning letters are lagging, CDRH recently uncovered 60 “confusing factors” impeding its performance and efforts are underway to weed them out, center officials say. The perplexing factors were discovered by an inter-office working group formed recently to address the “diminished impact” warning letters were having due to the timeliness troubles, CDRH Office of Compliance Director Steven Silverman said Wednesday.
Devices & Diagnostics Letter