Assessment of Obstetric and Gynecologic Food and Drug Administration Device Approvals and Recalls

ConclusionThe recall event rate for the 510(k) approval process is 13.6 times the rate for the PMA approval process for obstetric and gynecologic devices. Analysis of the results suggests improper device risk classification, inappropriate assignment of the approval process, increased device malfunctions, recalls by the 510(k) process and, therefore, increased risk to patients by these devices. This warrants a call for improvement and increased scrutiny in the 510(k) approval process for devices used in obstetrics and gynecology.
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research