Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.
Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.
- 2022
CONCLUSION: Otolaryngologic devices approved by the FDA via the 510(k) pathway exhibit a higher number of recalls than the PMA pathway. Given the balance between regulation and facilitating innovation, postmarket surveillance and ongoing regulatory improvements are critical to ensure optimal safety of medical devices. METHODS: The FDA Ear, Nose, and Throat Devices Panel database was queried for 510(k) clearances and PMA approvals from 1976 to 2019. Device recalls from 2003 to 2019 were reviewed. Devices were then categorized by subspecialty, type, supporting evidence, and PMA supplement type. Logistic regression characterized the odds of recall for each device type and subspeciality. OBJECTIVE: The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics. RESULTS: A total of 1061 (57.8%) 510(k) and 778 (42.3%) PMA device applications and modifications were approved. There were 120 (11.3%) recall events associated with 42 unique otolaryngologic devices cleared via the 510(k) pathway, as compared with 25 (3.2%) recall events for 5 unique PMA devices. 510(k) device approvals were more likely to be recalled than PMA device approvals (odds ratio, 3.67; 95% CI, 2.38-5.88; P < .0001). 510(k) surgical devices (odds ratio, 2.1; 95% CI, 1.1-4.4; P = .03) were more likely to be recalled than diagnostic devices. Devices designated for laryngology (70.0%) and general otolaryngology (25.0%) composed the majority of recalls. SETTING: Publicly available FDA databases. STUDY DESIGN: Retrospective cross-sectional analysis.
English
0194-5998
10.1177/01945998221085166 [doi]
IN PROCESS -- NOT YET INDEXED
MedStar Washington Hospital Center
MedStar Georgetown University Hospital/MedStar Washington Hospital Center
Otolaryngology
Otolaryngology Residency
Journal Article
CONCLUSION: Otolaryngologic devices approved by the FDA via the 510(k) pathway exhibit a higher number of recalls than the PMA pathway. Given the balance between regulation and facilitating innovation, postmarket surveillance and ongoing regulatory improvements are critical to ensure optimal safety of medical devices. METHODS: The FDA Ear, Nose, and Throat Devices Panel database was queried for 510(k) clearances and PMA approvals from 1976 to 2019. Device recalls from 2003 to 2019 were reviewed. Devices were then categorized by subspecialty, type, supporting evidence, and PMA supplement type. Logistic regression characterized the odds of recall for each device type and subspeciality. OBJECTIVE: The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics. RESULTS: A total of 1061 (57.8%) 510(k) and 778 (42.3%) PMA device applications and modifications were approved. There were 120 (11.3%) recall events associated with 42 unique otolaryngologic devices cleared via the 510(k) pathway, as compared with 25 (3.2%) recall events for 5 unique PMA devices. 510(k) device approvals were more likely to be recalled than PMA device approvals (odds ratio, 3.67; 95% CI, 2.38-5.88; P < .0001). 510(k) surgical devices (odds ratio, 2.1; 95% CI, 1.1-4.4; P = .03) were more likely to be recalled than diagnostic devices. Devices designated for laryngology (70.0%) and general otolaryngology (25.0%) composed the majority of recalls. SETTING: Publicly available FDA databases. STUDY DESIGN: Retrospective cross-sectional analysis.
English
0194-5998
10.1177/01945998221085166 [doi]
IN PROCESS -- NOT YET INDEXED
MedStar Washington Hospital Center
MedStar Georgetown University Hospital/MedStar Washington Hospital Center
Otolaryngology
Otolaryngology Residency
Journal Article