446 related articles for article (PubMed ID: 26063311)
1. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
Chang L; Dhruva SS; Chu J; Bero LA; Redberg RF
BMJ; 2015 Jun; 350():h2613. PubMed ID: 26063311
[TBL] [Abstract][Full Text] [Related]
2. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
Rathi VK; Krumholz HM; Masoudi FA; Ross JS
JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
[TBL] [Abstract][Full Text] [Related]
3. Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.
Swanson MJ; Johnston JL; Ross JS
Trials; 2021 Nov; 22(1):817. PubMed ID: 34789308
[TBL] [Abstract][Full Text] [Related]
4. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.
Dhruva SS; Bero LA; Redberg RF
JAMA; 2009 Dec; 302(24):2679-85. PubMed ID: 20040556
[TBL] [Abstract][Full Text] [Related]
5. Clinical 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
Otolaryngol Head Neck Surg; 2017 Feb; 156(2):285-288. PubMed ID: 28093943
[TBL] [Abstract][Full Text] [Related]
6. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM; Rathi VK; Grauer JN; Ross JS
Clin Orthop Relat Res; 2016 Apr; 474(4):1053-68. PubMed ID: 26584802
[TBL] [Abstract][Full Text] [Related]
7. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.
Dhruva SS; Bero LA; Redberg RF
Circ Cardiovasc Qual Outcomes; 2011 Mar; 4(2):165-71. PubMed ID: 21364127
[TBL] [Abstract][Full Text] [Related]
8. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.
Kramer DB; Mallis E; Zuckerman BD; Zimmerman BA; Maisel WH
Am J Ther; 2010; 17(1):2-7. PubMed ID: 20038828
[TBL] [Abstract][Full Text] [Related]
9. Publication 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
JAMA Intern Med; 2016 Apr; 176(4):551-2. PubMed ID: 26902933
[No Abstract] [Full Text] [Related]
10. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses.
Hart B; Lundh A; Bero L
BMJ; 2012 Jan; 344():d7202. PubMed ID: 22214754
[TBL] [Abstract][Full Text] [Related]
11. Incremental 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
Ophthalmology; 2017 Aug; 124(8):1237-1246. PubMed ID: 28501378
[TBL] [Abstract][Full Text] [Related]
12. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
Reynolds IS; Rising JP; Coukell AJ; Paulson KH; Redberg RF
JAMA Intern Med; 2014 Nov; 174(11):1773-9. PubMed ID: 25265209
[TBL] [Abstract][Full Text] [Related]
13. Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.
Fed Regist; 1998 Feb; 63(21):5387-93. PubMed ID: 10177333
[TBL] [Abstract][Full Text] [Related]
14. Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?
Fox-Rawlings SR; Gottschalk LB; Doamekpor LA; Zuckerman DM
Milbank Q; 2018 Sep; 96(3):499-529. PubMed ID: 30203600
[TBL] [Abstract][Full Text] [Related]
15. Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.
Seife C
JAMA Intern Med; 2015 Apr; 175(4):567-77. PubMed ID: 25664866
[TBL] [Abstract][Full Text] [Related]
16. An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.
Tylenda CA; Weintraub M
Ann Periodontol; 1997 Mar; 2(1):11-7. PubMed ID: 9151539
[TBL] [Abstract][Full Text] [Related]
17. Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.
Lee SJ; Cho L; Klang E; Wall J; Rensi S; Glicksberg BS
JAMA Netw Open; 2021 Jun; 4(6):e2112562. PubMed ID: 34156454
[TBL] [Abstract][Full Text] [Related]
18. US 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
Otolaryngol Head Neck Surg; 2017 Oct; 157(4):608-617. PubMed ID: 28786317
[TBL] [Abstract][Full Text] [Related]
19. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.
Ghobadi CW; Hayman EL; Finkle JH; Walter JR; Xu S
J Am Coll Radiol; 2017 Jan; 14(1):24-33. PubMed ID: 28061962
[TBL] [Abstract][Full Text] [Related]
20. Spinal devices in the United States-investigational device exemption trials and premarket approval of class III devices.
Golish SR; Reed ML
Spine J; 2017 Jan; 17(1):150-157. PubMed ID: 27737804
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
