These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

203 related articles for article (PubMed ID: 10167258)

  • 21. Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?
    Kelley P
    J Healthc Inf Manag; 2010; 24(3):36-40. PubMed ID: 20677470
    [TBL] [Abstract][Full Text] [Related]  

  • 22. Revisions to the general safety requirements for biological products--FD. Direct final rule.
    Fed Regist; 1998 Apr; 63(75):19399-403. PubMed ID: 10178869
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Letter to manufacturers of blood establishment computer software products--FDA. Notice.
    Fed Regist; 1994 Aug; 59(168):44991-2. PubMed ID: 10136917
    [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. Administrative practices and procedures; internal review of agency decisions---FDA. Direct final rule.
    Fed Regist; 1998 Jun; 63(115):32733-5. PubMed ID: 10180278
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Medical devices; investigational device exemptions--FDA. Final rule.
    Fed Regist; 1998 Nov; 63(225):64617-26. PubMed ID: 10338870
    [TBL] [Abstract][Full Text] [Related]  

  • 27. A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.
    Keatley KL
    Qual Assur; 1999; 7(2):77-89. PubMed ID: 10992873
    [TBL] [Abstract][Full Text] [Related]  

  • 28. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT; Hagie F; Keen CL; Gershwin ME
    Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
    [TBL] [Abstract][Full Text] [Related]  

  • 29. 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]  

  • 30. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.
    Fed Regist; 1998 Nov; 63(218):63222-53. PubMed ID: 10187398
    [TBL] [Abstract][Full Text] [Related]  

  • 31. The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?
    Kerouac JD
    J Biolaw Bus; 2002; 5(1):34-43. PubMed ID: 12751500
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal.
    Fed Regist; 1998 Aug; 63(166):45716-7. PubMed ID: 10182694
    [TBL] [Abstract][Full Text] [Related]  

  • 33. 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]  

  • 34. Exemption from federal preemption of state and local cigarette and smokeless tobacco requirements; revocation. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Nov; 65(216):66636. PubMed ID: 11503697
    [TBL] [Abstract][Full Text] [Related]  

  • 35. Medical devices; reclassification of six cardiovascular preamendments class III devices into class II. Final rule.
    Food and Drug Administration
    Fed Regist; 2001 Apr; 66(69):18540-2. PubMed ID: 11721689
    [TBL] [Abstract][Full Text] [Related]  

  • 36. HIPAA's impact on healthcare.
    Hellerstein D
    Health Manag Technol; 1999 Apr; 20(3):10-2, 14-5. PubMed ID: 10351268
    [TBL] [Abstract][Full Text] [Related]  

  • 37. 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]  

  • 38. Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule--FDA. Proposed rule.
    Fed Regist; 1998 Jun; 63(115):32772-4. PubMed ID: 10180279
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Administrative practices and procedures; internal agency review of decisions--FDA. Direct final rule; withdrawal.
    Fed Regist; 1998 Sep; 63(184):50757. PubMed ID: 10185804
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Medical devices; device tracking; new orders to manufacturers--FDA. Notice.
    Fed Regist; 1998 Mar; 63(42):10638-40. PubMed ID: 10177504
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 11.