used in the PMA process. The last presentation is an example of industry concerns about transparency of, and delays in, FDA decision-making within the 510(k) process.
The workshop agenda, biographic sketches of the speakers and panelists, and the two commissioned papers presented at the workshop are available as appendixes.
FDA (Food and Drug Administration). 2000. Device Advice: Premarket Notification. Washington, DC, Food and Drug Administration. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm (accessed August 31, 2010).
IOM (Institute of Medicine). 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation. Edited by Wizemann, T. Washington, DC: The National Academies Press.