203 related articles for article (PubMed ID: 18612007)
21. FDA regulatory pathways for knee cartilage repair products.
Levine DW; Mondano L; Halpin M
Sports Med Arthrosc Rev; 2008 Dec; 16(4):202-7. PubMed ID: 19011551
[TBL] [Abstract][Full Text] [Related]
22. Safe and effective medical devices--everyone's responsibility.
Franke KA
Gastroenterol Nurs; 1992 Apr; 14(5):245-8. PubMed ID: 1581379
[TBL] [Abstract][Full Text] [Related]
23. Don’t Try This at Home: the FDA’s Restrictive Regulation of Home Testing Devices.
Baird S
Duke Law J; 2017 Nov; 67(2):383-426. PubMed ID: 29469551
[TBL] [Abstract][Full Text] [Related]
24. 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]
25. Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.
Ashar BS; Dang JM; Krause D; Luke MC
Hernia; 2011 Dec; 15(6):603-5. PubMed ID: 21909977
[TBL] [Abstract][Full Text] [Related]
26. Medical devices; reclassification of the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2001 Feb; 66(40):12734-7. PubMed ID: 11503865
[TBL] [Abstract][Full Text] [Related]
27. Medical devices; reclassification of the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and the knee joint femorotibial (unicompartmental) metal/polymer porous-coated uncemented prosthesis. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2003 Mar; 68(56):14134-8. PubMed ID: 12653113
[TBL] [Abstract][Full Text] [Related]
28. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.
Yang BW; Iorio ML; Day CS
J Bone Joint Surg Am; 2017 Mar; 99(6):e26. PubMed ID: 28291189
[TBL] [Abstract][Full Text] [Related]
29. 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]
30. 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]
31. Medical devices: the obvious, the readily-accepted, and the surprising.
Tolomeo DE; Clarke LA
J Health Life Sci Law; 2008 Jul; 1(4):117, 119-44. PubMed ID: 18717154
[TBL] [Abstract][Full Text] [Related]
32. Off-Label Use in Orthopaedic Surgery.
Taylor BC; Triplet JJ; El-Sabawi T
J Am Acad Orthop Surg; 2019 Sep; 27(17):e767-e774. PubMed ID: 30550397
[TBL] [Abstract][Full Text] [Related]
33. Medical device labeling and advertising: an overview.
Basile EM; Armentrout E; Reeves KN
Food Drug Law J; 1999; 54(4):519-33. PubMed ID: 11824451
[TBL] [Abstract][Full Text] [Related]
34. Technology assessment of medical devices at the Center for Devices and Radiological Health.
Kessler L; Richter K
Am J Manag Care; 1998 Sep; 4 Spec No():SP129-35. PubMed ID: 10185989
[TBL] [Abstract][Full Text] [Related]
35. Off-label use of medical products in radiation therapy: summary of the report of AAPM Task Group No. 121.
Thomadsen BR; Heaton HT; Jani SK; Masten JP; Napolitano ME; Ouhib Z; Reft CS; Rivard MJ; Robin TT; Subramanian M; Suleiman OH
Med Phys; 2010 May; 37(5):2300-11. PubMed ID: 20527564
[TBL] [Abstract][Full Text] [Related]
36. Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.
Maxwell K
Am J Law Med; 2021 Jul; 47(2-3):291-326. PubMed ID: 34405782
[TBL] [Abstract][Full Text] [Related]
37. 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]
38. General and plastic surgery devices; effective date of requirement for premarket approval of the silicone inflatable breast prosthesis. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule.
Fed Regist; 1999 Aug; 64(160):45155-61. PubMed ID: 10558602
[TBL] [Abstract][Full Text] [Related]
39. CORR Insights®: How Do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Lavernia CJ; Villa JM
Clin Orthop Relat Res; 2016 Apr; 474(4):1069-71. PubMed ID: 26769621
[No Abstract] [Full Text] [Related]
40. Orthopedic devices: reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis. Final Rule.
Food and Drug Administration, HHS
Fed Regist; 2002 Apr; 67(83):21171-3. PubMed ID: 11982031
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
