2023
Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original ResearchUse of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia K, Dhruva S, Caraballo C, Ross J, Krumholz H. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA 2023, 329: 136-143. PMID: 36625810, PMCID: PMC9857464, DOI: 10.1001/jama.2022.23279.Peer-Reviewed Original Research
2022
Artificial Intelligence in Breast Cancer Screening
Potnis K, Ross J, Aneja S, Gross C, Richman I. Artificial Intelligence in Breast Cancer Screening. JAMA Internal Medicine 2022, 182: 1306-1312. PMID: 36342705, PMCID: PMC10623674, DOI: 10.1001/jamainternmed.2022.4969.Peer-Reviewed Original ResearchSensible regulation and clinical implementation of clinical decision support software as a medical device
Mori M, Jarrin R, Lu Y, Kadakia K, Huang C, Ross JS, Krumholz HM. Sensible regulation and clinical implementation of clinical decision support software as a medical device. The BMJ 2022, 376: o525. PMID: 35228206, DOI: 10.1136/bmj.o525.Commentaries, Editorials and LettersRenewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2021
Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020. JAMA Internal Medicine 2021, 181: 1409-1412. PMID: 34152383, PMCID: PMC8218229, DOI: 10.1001/jamainternmed.2021.3042.Peer-Reviewed Original ResearchMedicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?
Rathi VK, Johnston JL, Ross JS, Dhruva SS. Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown? New England Journal Of Medicine 2021, 384: e43. PMID: 33691059, DOI: 10.1056/nejmp2101874.Commentaries, Editorials and Letters
2020
Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Internal Medicine 2020, 180: 1701-1703. PMID: 33044513, PMCID: PMC7551221, DOI: 10.1001/jamainternmed.2020.3214.Peer-Reviewed Original ResearchMandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products
Dhruva SS, Shah ND, Ross JS. Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products. Mayo Clinic Proceedings 2020, 95: 2609-2611. PMID: 33289654, DOI: 10.1016/j.mayocp.2020.04.013.Commentaries, Editorials and LettersPostmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Network Open 2020, 3: e2014496. PMID: 32857145, PMCID: PMC7455850, DOI: 10.1001/jamanetworkopen.2020.14496.Peer-Reviewed Original ResearchEarly experience with the FDA’s Breakthrough Devices program
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Early experience with the FDA’s Breakthrough Devices program. Nature Biotechnology 2020, 38: 933-938. PMID: 32704171, DOI: 10.1038/s41587-020-0636-7.Peer-Reviewed Original Research
2019
Modernizing the FDA’s 510(k) Pathway
Rathi VK, Ross JS. Modernizing the FDA’s 510(k) Pathway. New England Journal Of Medicine 2019, 381: 1891-1893. PMID: 31644865, DOI: 10.1056/nejmp1908654.Commentaries, Editorials and LettersThe Bleeding Edge
Pendyal A, Ross JS. The Bleeding Edge. JAMA 2019, 322: 190-192. PMID: 31310276, DOI: 10.1001/jama.2019.8147.Commentaries, Editorials and LettersAssociation Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015
ZHANG AD, SCHWARTZ JL, ROSS JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015. Milbank Quarterly 2019, 97: 796-819. PMID: 31304643, PMCID: PMC6739629, DOI: 10.1111/1468-0009.12403.Peer-Reviewed Original Research
2017
Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices
Dhruva SS, Mazure CM, Ross JS, Redberg RF. Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices. JAMA Internal Medicine 2017, 177: 1390-1391. PMID: 28738116, PMCID: PMC5818834, DOI: 10.1001/jamainternmed.2017.3148.Peer-Reviewed Original ResearchUS Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologicIncremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015
Gopal AD, Rathi VK, Teng CC, Del Priore L, Ross JS. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015. Ophthalmology 2017, 124: 1237-1246. PMID: 28501378, DOI: 10.1016/j.ophtha.2017.03.040.Peer-Reviewed Original ResearchClinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High‐Risk Otolaryngologic Devices, 2000‐2014. Otolaryngology 2017, 156: 285-288. PMID: 28093943, DOI: 10.1177/0194599816684094.Peer-Reviewed Original ResearchConceptsPostapproval studiesPivotal studiesUS FoodPrimary effectiveness end pointAvailable FDA documentsEffectiveness end pointPivotal clinical studiesBenefit-risk assessmentCross-sectional analysisPremarket evidenceMedian durationClinical evidenceDrug Administration premarket approvalsOtolaryngologic diseaseMedian enrollmentClinical studiesHigh-risk medical devicesDrug AdministrationEnd pointHigh-risk devicesFDA documentsOne-thirdTwo-thirdsPremarket approvalFDA
2016
The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?
Rathi VK, Kesselheim AS, Ross JS. The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices? JAMA Cardiology 2016, 1: 117. PMID: 27437879, DOI: 10.1001/jamacardio.2016.0002.Commentaries, Editorials and LettersPublication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study
Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA Internal Medicine 2016, 176: 551. PMID: 26902933, DOI: 10.1001/jamainternmed.2015.8590.Peer-Reviewed Original Research