{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:46:56Z","timestamp":1791931616154,"version":"4.3.4"},"reference-count":41,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,1,10]]},"abstract":"\n Importance<\/jats:title>\n In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall\u2014the FDA\u2019s most serious designation indicating a high probability of adverse health consequences or death\u2014as predicates for new devices. The consequences for patient safety are not known.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway.<\/jats:p>\n <\/jats:sec>\n \n Design and Setting<\/jats:title>\n In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA\u2019s annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40];\n P<\/jats:italic>\n &amp;lt;.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2022.23279","type":"journal-article","created":{"date-parts":[[2023,1,10]],"date-time":"2023-01-10T11:06:58Z","timestamp":1673348818000},"page":"136","source":"Crossref","is-referenced-by-count":38,"title":["Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration\u2019s 510(k) Pathway and Risk of Subsequent Recalls"],"prefix":"10.1001","volume":"329","author":[{"given":"Kushal T.","family":"Kadakia","sequence":"first","affiliation":[{"name":"Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanket S.","family":"Dhruva","sequence":"additional","affiliation":[{"name":"Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco"},{"name":"Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e9sar","family":"Caraballo","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut"},{"name":"Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut"},{"name":"Section of General Internal Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut"},{"name":"Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harlan M.","family":"Krumholz","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut"},{"name":"Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut"},{"name":"Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"5","key":"joi220140r1","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1001\/jama.2021.11171","article-title":"FDA regulation and approval of medical devices, 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