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Failure to submit medical device reports for its total parenteral nutrition bags landed the Metrix Company an eight-item Form 483 following a May 2016 inspection of its Dubuque, Iowa, facility. 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
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