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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
Certain Class II device manufacturers will get two more years to comply with the FDA’s unique device identifier rule that was scheduled to become effective Sept. 24. Read More
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
Cook Medical announced a global recall of 8,750 units of its Roadrunner UniGlide hydrophilic wire guides due to the possibility of glass particles in the coating of the wire guide units. Read More
The FDA is once again warning healthcare facilities to stop using an endoscope reprocessor system from Custom Ultrasonics to disinfect duodenoscopes. Read More
The FDA has asked manufacturers of syringe pumps to update their labels to address flow continuity concerns that the agency identified as a serious risk to health. Read More
Alere said it will remove its INRatio and INRatio2 PT/INR monitoring system from the market and discontinue manufacturing the product line following a Class I recall due to inaccurate test results. Read More
The FDA handed a warning letter to Tosoh Bioscience, an importer of assays and high performance liquid chromatographs, for failing to properly manage its suppliers and handle complaints. Read More