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Data from patients will add to the body of evidence used to assess devices, both in the approval process and for postmarket safety, FDA Commissioner Robert Califf told devicemakers. Read More
Failure to establish corrective and preventive action procedures as well as procedures for receiving and reviewing complaints landed Texas-based Simpro an FDA warning letter. Read More
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. Read More