130 related articles for article (PubMed ID: 10557868)
1. "Home brew" laboratory tests.
Kisner HJ
Clin Lab Manage Rev; 1999; 13(2):104-6. PubMed ID: 10557868
[No Abstract] [Full Text] [Related]
2. Coping with the IVD directive.
Gower G
Med Device Technol; 2000 Oct; 11(8):28-9. PubMed ID: 11185185
[TBL] [Abstract][Full Text] [Related]
3. Understanding US labelling requirements.
Donawa M
Med Device Technol; 2005 Sep; 16(7):21-3. PubMed ID: 16259155
[TBL] [Abstract][Full Text] [Related]
4. Home-brew tests need regulation.
Nature; 2014 Aug; 512(7512):5. PubMed ID: 25100448
[No Abstract] [Full Text] [Related]
5. Pharmaceuticals and medical devices: medical devices. Issue brief.
Berry MD
Issue Brief Health Policy Track Serv; 2012 Dec; ():1-35. PubMed ID: 23297445
[No Abstract] [Full Text] [Related]
6. FDA's proposed regulatory approach to regulation of hematopoietic stem/progenitor cell products.
Harvath L
Cytotherapy; 1999; 1(4):358-9. PubMed ID: 20440912
[No Abstract] [Full Text] [Related]
7. Differing definitions of manufacturer.
Donawa ME
Med Device Technol; 1998; 9(6):14-7. PubMed ID: 10182120
[TBL] [Abstract][Full Text] [Related]
8. FDA pilot programme in support of global harmonisation.
Donawa ME
Med Device Technol; 2003 Nov; 14(9):32-4. PubMed ID: 14682021
[TBL] [Abstract][Full Text] [Related]
9. Organising European technical documentation to avoid duplication.
Donawa M
Med Device Technol; 2006 Apr; 17(3):29-31. PubMed ID: 16736662
[TBL] [Abstract][Full Text] [Related]
10. Keeping waived tests simple.
Clin Leadersh Manag Rev; 2004; 18(1):65-9. PubMed ID: 14968759
[TBL] [Abstract][Full Text] [Related]
11. News from the latest CLIAC meeting.
Pontius CA
MLO Med Lab Obs; 2001 Jul; 33(7):38-40. PubMed ID: 11467173
[No Abstract] [Full Text] [Related]
12. How FDA-recognized standards impact users, manufacturers.
Osborn D
Biomed Instrum Technol; 2009; 43(2):156-7. PubMed ID: 19480488
[No Abstract] [Full Text] [Related]
13. Coping with CLIA, Part 7. Walking the straight and narrow on quality control.
Passey RB
MLO Med Lab Obs; 1993 Feb; 25(2):39-43. PubMed ID: 10171371
[No Abstract] [Full Text] [Related]
14. FDA weighing feasibility of at-home testing for AIDS virus.
AIDS Read; 2005 Nov; 15(11):574. PubMed ID: 16331828
[No Abstract] [Full Text] [Related]
15. Standards struggle. Suppliers question push for lone device ID system.
Rhea S
Mod Healthc; 2010 Jul; 40(28):10. PubMed ID: 20669379
[No Abstract] [Full Text] [Related]
16. FDA announces final rule establishing UDI system for medical devices.
Health Devices; 2013 Nov; 42(11):383. PubMed ID: 24358514
[No Abstract] [Full Text] [Related]
17. FDA and CLIA oversight of advanced diagnostics and biomarker tests.
Terry SF
Genet Test Mol Biomarkers; 2010 Jun; 14(3):285-7. PubMed ID: 20578940
[No Abstract] [Full Text] [Related]
18. Tagging the issues surrounding auto-ID labels.
Sparnon E
Biomed Instrum Technol; 2006; Suppl():25-6. PubMed ID: 16596846
[No Abstract] [Full Text] [Related]
19. FDA ignores CLIA and moves to regulate clinical laboratories.
Killingsworth LM
Clin Chem; 1993 Feb; 39(2):179-80. PubMed ID: 8432005
[No Abstract] [Full Text] [Related]
20. US Food and Drug Administration proposes federal regulation of labeling of latex-containing medical devices.
Kedas AM; Dillard S; Tomazic V
AORN J; 1996 Aug; 64(2):290-2. PubMed ID: 8853787
[No Abstract] [Full Text] [Related]
[Next] [New Search]
