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

Study Objective: To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes.

Design: A retrospective observational study (Canadian Task Force classification II-2).

Setting: Clinical settings in the United States that use obstetric and gynecologic devices.

Subjects: Two thousand two hundred forty-nine Food and Drug Administration-approved obstetric and gynecologic devices that were recalled between November 1, 2002, and December 31, 2017.

Measurements And Main Results: The class of device, class of recall, date of recall, and original approval process were obtained for each device. These were compared against the total number of approved devices during this time period in the PMA and 510(k) processes. Recall proportions of each process were calculated and compared. A total of 685 devices were approved via the PMA process, and 1564 devices were approved via the 510(k) process in the observed time period. Of these, 1.17% of the PMA-approved devices and 15.98% of the 510(k)-approved devices were recalled (p < .001). There was an overall increase in absolute device recall numbers over time in the 510(k) process, whereas the number of recalls in the PMA process did not change with time.

Conclusion: The 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.