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The International Medical Device Regulators Forum’s single-audit program remains on track for full implementation in 2019, and companies should be shoring up their internal auditing processes to prepare. Read More
Collagen Matrix has received a warning letter after the FDA found cGMP violations and quality system issues with its devices for use in oral/maxillofacial, neurosurgery and orthopedic-spine surgery. Read More
FDA guidance on risk-benefit decisionmaking in premarket device approvals should include multiple factors for determining whether a device presents low risk, the Medical Imaging & Technology Alliance said in comments on the final guidance. Read More
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