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Pain and bleeding were reduced in a clinical trial testing Aspivix’s Carevix cervical stabilizer device against a standard tenaculum — used to stabilize the cervix to ease passage of instruments — among women undergoing intrauterine device (IUD) placement to prevent pregnancy.
North Carolina-based Carolina Biological Supply was handed a Form 483 for lacking adequate procedures for corrective and preventative actions (CAPA), medical device reporting (MDR) and audits, among other lapses.
Having operational logistics in place for your FDA inspection means writing down the inspection plan beforehand in a standard operating procedure (SOP), starting with the moment the investigators walk in the door, advised inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
Four out of 10 women don’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which leads to additional visits because of persistent symptoms, the company said.
Among the many requirements to bring your product to market is to have accurate labeling — as well as procedures in place to ensure that and any new intended uses are included.
The FDA handed Oak Ridge Products a Form 483 for a lack of design control documents as well as inadequate corrective and preventive action (CAPA) procedures and complaint handling, among other lapses.
The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.
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