Importance: Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical devices with similar intended use). Most recalled medical devices are 510(k) devices.

Objective: To examine the association between characteristics of predicate medical devices and recall probability for 510(k) devices.

Design, Setting, And Participants: In this exploratory cross-sectional analysis of medical devices cleared by the US Food and Drug Administration (FDA) between 2003 and 2018 via the 510(k) regulatory submission pathway, linear probability models were used to examine associations between a 510(k) device's recall status and characteristics of its predicate medical devices. Public documents for the 510(k) medical devices were collected using FDA databases. A text extraction algorithm was applied to identify predicate medical devices cited in 510(k) regulatory submissions. Algorithm-derived metadata were combined with 2003-2020 FDA recall data.

Exposures: Citation of predicate medical devices with certain characteristics in 510(k) regulatory submissions, including the total number of predicate medical devices cited by the applicant device, the age of the predicate medical devices, the lack of similarity of the predicate medical devices to the applicant device, and the recall status of the predicate medical devices.

Main Outcomes And Measures: Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020.

Results: The sample included 35 176 medical devices, of which 4007 (11.4%) were recalled. The applicant devices cited a mean of 2.6 predicate medical devices, with mean ages of 3.6 years and 7.4 years for the newest and oldest, respectively, predicate medical devices. Of the applicant devices, 93.9% cited predicate medical devices with no ongoing recalls, 4.3% cited predicate medical devices with 1 ongoing class I or class II recall, 1.0% cited predicate medical devices with 2 ongoing recalls, and 0.8% cited predicate medical devices with 3 or more ongoing recalls. Applicant devices citing predicate medical devices with 3 or more ongoing recalls were significantly associated with a 9.31-percentage-point increase (95% CI, 2.84-15.77 percentage points) in recall probability compared with devices without ongoing recalls of predicate medical devices, or an 81.2% increase in recall probability relative to the mean recall probability. A 1-SD increase in the total number of predicate medical devices cited by the applicant device was significantly associated with a 1.25-percentage-point increase (95% CI, 0.62-1.87 percentage points) in recall probability, or an 11.0% increase in recall probability relative to the mean recall probability. A 1-SD increase in the newest age of a predicate medical device was significantly associated with a 0.78-percentage-point decrease (95% CI, 1.29-0.30 percentage points) in recall probability, or a 6.8% decrease in recall probability relative to the mean recall probability.

Conclusions And Relevance: This exploratory cross-sectional study of 510(k) medical devices cleared by the FDA between 2003 and 2018 demonstrated significant associations between 510(k) submission characteristics and recalls of medical devices. Further research is needed to understand the implications of these associations.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9857565PMC
http://dx.doi.org/10.1001/jama.2022.22974DOI Listing

Publication Analysis

Top Keywords

medical devices
100
predicate medical
72
recall probability
36
devices
31
medical
28
devices ongoing
24
cited predicate
20
ongoing recalls
20
predicate
18
510k regulatory
16

Similar Publications

Combining Hard Shell with Soft Core to Enhance Enzyme Activity and Resist External Disturbances.

Adv Sci (Weinh)

January 2025

Department of Cardiology, The First People's Hospital of Wenling, Wenling Hospital of Wenzhou Medical University, Wenling, Zhejiang, 317500, China.

Immobilizing enzymes onto solid supports having enhanced catalytic activity and resistance to harsh external conditions is considered as a promising and critical method of broadening enzymatic applications in biosensing, biocatalysis, and biomedical devices; however, it is considerably hampered by limited strategies. Here, a core-shell strategy involving a soft-core hexahistidine metal assembly (HmA) is innovatively developed and characterized with encapsulated enzymes (catalase (CAT), horseradish peroxidase, glucose oxidase (GOx), and cascade enzymes (CAT+GOx)) and hard porous shells (zeolitic imidazolate framework (ZIF), ZIF-8, ZIF-67, ZIF-90, calcium carbonate, and hydroxyapatite). The enzyme-friendly environment provided by the embedded HmA proves beneficial for enhanced catalytic activity, which is particularly effective in preserving fragile enzymes that will have been deactivated without the HmA core during the mineralization of porous shells.

View Article and Find Full Text PDF

Photobiomodulation Combined With Human Umbilical Cord Mesenchymal Stem Cells Modulates the Polarization of Microglia.

J Biophotonics

January 2025

State Key Laboratory of Advanced Medical Materials and Devices, Tianjin Key Laboratory of Neuromodulation and Neurorepair, Integrative regeneration laboratory, Institute of Biomedical Engineering, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.

Neuroinflammation plays a key role in the development of neurodegenerative diseases, with microglia regulating this process through pro-inflammatory M1 and anti-inflammatory M2 phenotypes. Studies have shown that human umbilical cord mesenchymal stem cells (hUCMSCs) modulate neuroinflammation by secreting anti-inflammatory cytokines. Photobiomodulation (PBM), a non-invasive therapy, has demonstrated significant potential in alleviating neuroinflammation.

View Article and Find Full Text PDF

Two-dimensional inverse double sandwich CoB: strain-induced non-magnetic to ferromagnetic transition.

Phys Chem Chem Phys

January 2025

Key Laboratory of Material Chemistry for Energy Conversion and Storage, Ministry of Education, Hubei Key Laboratory of Materials Chemistry and Service Failure, Hubei Key Laboratory of Bioinorganic Chemistry and Materia Medica, Hubei Engineering Research Center for Biomaterials and Medical Protective Materials, School of Chemistry and Chemical Engineering, Huazhong University of Science and Technology, Wuhan 430074, China.

A full-scale structural search was performed using density functional theory calculations and a universal structural prediction evolutionary algorithm. This produced a lowest energy two-dimensional (2D) CoB structure. The CoB-1 global minimum structure has unusual inverse double sandwich features.

View Article and Find Full Text PDF

Purpose: The aim of this study was to evaluate the efficacy and safety of the Ahmed glaucoma valve in pediatric patients with refractory glaucoma.

Methods: A comprehensive literature search was conducted across multiple major databases, including PubMed, Embase, the Cochrane Library of Systematic Reviews, Science Direct, China's National Knowledge Infrastructure, and the Wanfang database. We retrieved studies published before December 2022 that met the inclusion criteria, including clinical controlled trials (randomized controlled trials) and clinical noncontrolled trials (non-randomized controlled trials) on the use of Ahmed glaucoma valve in pediatric patients with refractory glaucoma.

View Article and Find Full Text PDF

Firefighters are exposed to the risk of burns at fire scenes. In 2020, the National Fire Agency of the Republic of Korea surveyed 50,527 firefighters and identified 242 burn-related incidents. The body parts affected by these burns were the hands (28.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!