Medical Device Regulation: Time to Improve Performance
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Vyšlo v časopise:
Medical Device Regulation: Time to Improve Performance. PLoS Med 9(7): e32767. doi:10.1371/journal.pmed.1001277
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Perspective
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1001277
Souhrn
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Zdroje
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3. KramerDB, XuS, KesselheimAS (2012) How does medical device regulation perform in the US and EU? A systematic review. PLoS Med 9: e1001276 doi:10.1371/journal.pmed.1001276.
4. ZuckermanDM, BrownP, NissenSE (2011) Medical device recalls and the FDA approval process. Arch Intern Med 171: 1006–1011.
5. HallRF (April 13, 2011) Delicate balance: FDA and the reform of the medical device approval process. Written testimony for U.S. Senate Committee on Aging. Available: http://aging.senate.gov/events/hr233hr.pdf. Accessed 22 April 2012.
6. U.S. House of Representatives Committee on Energy and Commerce (2011) Medical journal editors raise significant concerns with validity of industry-funded reports. July 21, 2011. Available: http://democrats.energycommerce.house.gov/index.php?q=news/medical-journal-editors-raise-significant-concerns-with-validity-of-industry-funded-reports. Accessed 1 May 2012.
7. MakowerJ (2011) Impact of medical device regulation on jobs and patients. Written testimony for the U.S. House of Representatives Committee on Energy and Commerce. February 17, 2011. Available: http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=8221. Accessed 29 June 2012.
8. OkieS (2010) Reviving the FDA. N Engl J Med 363: 1492–1494.
9. MakowerJ, MeerA, DenendL (2010) FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. November 2010
10. HinesJZ, LurieP, YuE, WolfeS (2010) Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med 7: e1000280 doi:10.1371/journal.pmed.1000280.
11. BurgessM (2011) Comments in “Impact of Medical Device Regulation on Jobs and Patients.”. House of Representatives, Subcommittee on Health, Committee on Energy and Commerce. February 17, 2011.
12. FraserAG, DaubertJ-C, Van De WerfF, EstesM, SmithSC, et al. (2011) Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology. Eur Heart J 32: 1673–1686.
13. ThompsonM, HeneghanC, BillingsleyM, CohenD (2011) Medical device recalls and transparency in the UK. BMJ 342: d2973.
14. O'ConnorAB (2009) The need for improved access to FDA reviews. JAMA 302: 191–193.
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