263 related articles for article (PubMed ID: 27207165)
41. 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]
42. Medical Devices; Exemptions From Premarket Notification: Class II Devices. Final order.
Food and Drug Administration, HHS
Fed Regist; 2018 Jun; 83(108):25910-5. PubMed ID: 30019871
[TBL] [Abstract][Full Text] [Related]
43. 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]
44. 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]
45. Medical device regulation for manufacturers.
McAllister P; Jeswiet J
Proc Inst Mech Eng H; 2003; 217(6):459-67. PubMed ID: 14702983
[TBL] [Abstract][Full Text] [Related]
46. 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]
47. Medical devices on trial, Part I.
Wright D
Med Device Technol; 2002 Dec; 13(10):35-8. PubMed ID: 12575529
[TBL] [Abstract][Full Text] [Related]
48. Post-approval studies in France, challenges facing medical devices.
Levesque K; Coqueblin C; Guillot B; ; Aubourg L; Avouac B; Carbonneil C; Cucherat M; Descamps-Mandine P; Hanoka S; Goldberg M; Josseran A; Parquin F; Pitel S; Ratignier C; Sechoy O; Szwarcenstein K; Tanti A; Teiger E; Thevenet N
Therapie; 2014; 69(4):303-21. PubMed ID: 25230354
[TBL] [Abstract][Full Text] [Related]
49. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.
Kadakia KT; Dhruva SS; Caraballo C; Ross JS; Krumholz HM
JAMA; 2023 Jan; 329(2):136-143. PubMed ID: 36625810
[TBL] [Abstract][Full Text] [Related]
50. Medical devices; retention in class III and effective date of requirement for premarket approval for three preamendments class III devices--FDA. Proposed rule; opportunity to request a change in classification.
Fed Regist; 1998 Jul; 63(146):40673-7. PubMed ID: 10181520
[TBL] [Abstract][Full Text] [Related]
51. FDA user fee and Modernisation Act.
Donawa M
Med Device Technol; 2002 Dec; 13(10):27-9. PubMed ID: 12575526
[TBL] [Abstract][Full Text] [Related]
52. Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.
Fed Regist; 1998 Nov; 63(212):59222-31. PubMed ID: 10187384
[TBL] [Abstract][Full Text] [Related]
53. Postmarketing trials and pediatric device approvals.
Hwang TJ; Kesselheim AS; Bourgeois FT
Pediatrics; 2014 May; 133(5):e1197-202. PubMed ID: 24733871
[TBL] [Abstract][Full Text] [Related]
54. FDA's new regulatory paradigms for in vitro diagnostic devices.
Robinowitz M; Gutman SI
Cytotherapy; 1999; 1(4):353-7. PubMed ID: 20426566
[No Abstract] [Full Text] [Related]
55. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.
Feldman MD; Petersen AJ; Karliner LS; Tice JA
J Gen Intern Med; 2008 Jan; 23 Suppl 1(Suppl 1):57-63. PubMed ID: 18095046
[TBL] [Abstract][Full Text] [Related]
56. Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal.
Fed Regist; 1998 Aug; 63(154):42699. PubMed ID: 10182563
[TBL] [Abstract][Full Text] [Related]
57. How do regulatory agencies ensure the release of a safe medical device?
Haggar B
Clin Perform Qual Health Care; 1999; 7(2):100-3. PubMed ID: 10747561
[TBL] [Abstract][Full Text] [Related]
58. Europeans are left to their own devices.
Cohen D; Billingsley M
BMJ; 2011 May; 342():d2748. PubMed ID: 21572130
[No Abstract] [Full Text] [Related]
59. Approval process for devices and mesh for surgical treatment of pelvic organ prolapse and urinary incontinence.
Nygaard I
Clin Obstet Gynecol; 2013 Jun; 56(2):229-31. PubMed ID: 23632639
[TBL] [Abstract][Full Text] [Related]
60. FDA medical device approval: things you didn't learn in medical school or residency.
Buch B
Am J Orthop (Belle Mead NJ); 2007 Aug; 36(8):407-12. PubMed ID: 17849025
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]