REFERENCES FOR TOPIC #3

 

  1. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, Office of Device Evaluation, CDRH, April 1996

http://www.fda.gov/cdrh/ode/198.pdf

 

  1. Updated 510(k) Sterility Review, Guidance K90-1; Final Guidance for Industry and FDA, Office of Device Evaluation, CDRH, August 30, 2002

            http://www.fda.gov/cdrh/ode/guidance/361.html

 

 

See also the WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies, provided with References Relating to Speaker Presentations for Topics 3 & 4,  item #1.