200 related articles for article (PubMed ID: 32221981)
21. Food and Drug Association Approval Process for Devices Used in Endovascular Treatment of Stroke.
Gangadhara S; Siddiqui A; Mokin M
Neurology; 2021 Nov; 97(20 Suppl 2):S194-S200. PubMed ID: 34785618
[TBL] [Abstract][Full Text] [Related]
22. Regulation of Medical Devices for Dermatology.
Halachmi S; Marquart L
Dermatol Clin; 2022 Jul; 40(3):297-305. PubMed ID: 35750413
[TBL] [Abstract][Full Text] [Related]
23. 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]
24. Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories.
Ghobadi CW; Janetos TM; Tsai S; Welty L; Walter JR; Xu S
Issues Law Med; 2019; 34(1):77-92. PubMed ID: 31179672
[TBL] [Abstract][Full Text] [Related]
25. Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.
Lefkovich C; Rothenberg S
PLoS One; 2023; 18(3):e0283442. PubMed ID: 36976820
[TBL] [Abstract][Full Text] [Related]
26. The Interconnected Ancestral Network of Hip Arthroplasty Device Approval.
Premkumar A; Zhu A; Ying X; Pean CA; Sheth NP; Cross MB; Gonzalez Della Valle A
J Am Acad Orthop Surg; 2021 Dec; 29(24):e1362-e1369. PubMed ID: 34161960
[TBL] [Abstract][Full Text] [Related]
27. Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.
Rathi VK; Ross JS; Samuel AM; Mehra S
Otolaryngol Head Neck Surg; 2015 Sep; 153(3):400-8. PubMed ID: 26044785
[TBL] [Abstract][Full Text] [Related]
28. Medical devices: US medical device regulation.
Jarow JP; Baxley JH
Urol Oncol; 2015 Mar; 33(3):128-32. PubMed ID: 25458071
[TBL] [Abstract][Full Text] [Related]
29. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
Rome BN; Kramer DB; Kesselheim AS
JAMA; 2014 Jan 22-29; 311(4):385-91. PubMed ID: 24449317
[TBL] [Abstract][Full Text] [Related]
30. Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia.
Wang S; Seth D; Ezaldein H; Tripathi R; Merati M; Muakkassa F; Scott J
J Dermatolog Treat; 2019 Aug; 30(5):489-491. PubMed ID: 30252550
[No Abstract] [Full Text] [Related]
31. FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.
Muehlematter UJ; Bluethgen C; Vokinger KN
Lancet Digit Health; 2023 Sep; 5(9):e618-e626. PubMed ID: 37625896
[TBL] [Abstract][Full Text] [Related]
32. 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]
33. Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices.
Shapiro JK
Food Drug Law J; 2014; 69(3):365-97, i. PubMed ID: 27382855
[TBL] [Abstract][Full Text] [Related]
34. 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]
35. An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
Peña C; Bowsher K; Costello A; De Luca R; Doll S; Li K; Schroeder M; Stevens T
IEEE Trans Neural Syst Rehabil Eng; 2007 Sep; 15(3):421-4. PubMed ID: 17894274
[TBL] [Abstract][Full Text] [Related]
36. United States Food and Drug Administration's 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices.
Wang S; Manudhane A; Ezaldein HH; Scott JF
Cureus; 2019 Mar; 11(3):e4230. PubMed ID: 31123652
[TBL] [Abstract][Full Text] [Related]
37. The Food and Drug Administration's Role in Dermatologic Drug Development.
Lewis FS; Marcus KA
Dermatol Clin; 2022 Jul; 40(3):249-263. PubMed ID: 35750409
[TBL] [Abstract][Full Text] [Related]
38. Regulatory approval of new medical devices: cross sectional study.
Marcus HJ; Payne CJ; Hughes-Hallett A; Marcus AP; Yang GZ; Darzi A; Nandi D
BMJ; 2016 May; 353():i2587. PubMed ID: 27207165
[TBL] [Abstract][Full Text] [Related]
39. Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety.
Janetos TM; Ghobadi CW; Xu S; Walter JR
Am J Obstet Gynecol; 2017 Jul; 217(1):42-46.e1. PubMed ID: 28500861
[TBL] [Abstract][Full Text] [Related]
40.
; ; . PubMed ID:
[No Abstract] [Full Text] [Related]
[Previous] [Next] [New Search]