307 related articles for article (PubMed ID: 28786317)
21. Medical devices; substantial equivalence; 510(K) summaries and 510(K) statements; class III summaries; confidentiality of information--FDA. Final rule.
Fed Regist; 1994 Dec; 59(239):64287-96. PubMed ID: 10139433
[TBL] [Abstract][Full Text] [Related]
22. 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]
23. Medical device recall authority--FDA. Final rule.
Fed Regist; 1996 Nov; 61(225):59004-22. PubMed ID: 10163116
[TBL] [Abstract][Full Text] [Related]
24. 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]
25. Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
Scott B
Food Drug Law J; 2011; 66(3):377-404, ii. PubMed ID: 24505854
[TBL] [Abstract][Full Text] [Related]
26. 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]
27. Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review.
Phi NTT; Oikonomidi T; Ravaud P; Tran VT
JAMA Intern Med; 2023 Aug; 183(8):858-869. PubMed ID: 37459057
[TBL] [Abstract][Full Text] [Related]
28. 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]
29. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.
Heneghan CJ; Goldacre B; Onakpoya I; Aronson JK; Jefferson T; Pluddemann A; Mahtani KR
BMJ Open; 2017 Dec; 7(12):e017125. PubMed ID: 29212782
[TBL] [Abstract][Full Text] [Related]
30. Food and Drug Administration regulation of in vitro diagnostic devices.
Mansfield E; O'Leary TJ; Gutman SI
J Mol Diagn; 2005 Feb; 7(1):2-7. PubMed ID: 15681468
[TBL] [Abstract][Full Text] [Related]
31. Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.
Ronquillo JG; Zuckerman DM
Milbank Q; 2017 Sep; 95(3):535-553. PubMed ID: 28895231
[TBL] [Abstract][Full Text] [Related]
32. 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]
33. FDA Regulation and Approval of Medical Devices: 1976-2020.
Darrow JJ; Avorn J; Kesselheim AS
JAMA; 2021 Aug; 326(5):420-432. PubMed ID: 34342614
[TBL] [Abstract][Full Text] [Related]
34. Shoulder arthroplasty device clearance: an ancestral network analysis.
Zhu A; Ying X; Carey EG; Pean CA; Premkumar A; Fu MC; Taylor SA
J Shoulder Elbow Surg; 2023 Mar; 32(3):671-676. PubMed ID: 36279987
[TBL] [Abstract][Full Text] [Related]
35. The regulatory ancestral network of surgical meshes.
Zargar N; Carr A
PLoS One; 2018; 13(6):e0197883. PubMed ID: 29920525
[TBL] [Abstract][Full Text] [Related]
36. 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]
37. The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.
Dubin JR; Ibad H; Cil A; Murray M
J Am Acad Orthop Surg; 2022 Jul; 30(14):658-667. PubMed ID: 35797679
[TBL] [Abstract][Full Text] [Related]
38. Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.
Kadakia KT; Beckman AL; Ross JS; Krumholz HM
JAMA Intern Med; 2022 Jan; 182(1):59-65. PubMed ID: 34842892
[TBL] [Abstract][Full Text] [Related]
39. Assessment of Obstetric and Gynecologic Food and Drug Administration Device Approvals and Recalls.
Galhotra S; Maurice J
J Minim Invasive Gynecol; 2018; 25(7):1281-1288. PubMed ID: 29653261
[TBL] [Abstract][Full Text] [Related]
40. Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance.
Everhart AO; Sen S; Stern AD; Zhu Y; Karaca-Mandic P
JAMA; 2023 Jan; 329(2):144-156. PubMed ID: 36625811
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]