These are the sources and citations used to research 510(k). This bibliography was generated on Cite This For Me on
In-text: (510(k) Basics - 510k.net - A Comprehensive Analysis of the FDA 510(k) Process - Research Study - Linehan, Pietzsch, 2015)
Your Bibliography: 510k.net. 2015. 510(k) Basics - 510k.net - A Comprehensive Analysis of the FDA 510(k) Process - Research Study - Linehan, Pietzsch. [online] Available at: <http://www.510k.net/basics.html> [Accessed 23 January 2015].
In-text: (Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors, 2006)
Your Bibliography: 2006. Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors. 1st ed. [ebook] Available at: <http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf> [Accessed 23 January 2015].
In-text: (The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff, 2014)
Your Bibliography: 2014. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff. [online] Available at: <http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf> [Accessed 23 January 2015].
In-text: (What Does Having a FDA Cleared Pregnancy Test Mean?, 2015)
Your Bibliography: Ctti-clinicaltrials.org. 2015. What Does Having a FDA Cleared Pregnancy Test Mean?. [online] Available at: <http://www.ctti-clinicaltrials.org/files/Pregnancy_Testing/5%20Johnson-Lyles%20CTTI%20Pregnancy%20Meeting%207-15-13.pdf?&session-id=a7c9f9e9633d2c88e0ee37050a94931a> [Accessed 23 January 2015].
In-text: (Sarata and Johnson, 2014)
Your Bibliography: Sarata, A. and Johnson, J., 2014. Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests. 1st ed. [ebook] Available at: <http://www.fas.org/sgp/crs/misc/R43438.pdf> [Accessed 23 January 2015].
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