Dear all,

I can't find at the FDA website wether a temperature indication (for storage) of In Vitro Medical devices should be either in degrees ceelcius (°C) or degrees Fahrenheit (°F) or perhaps even both.
Does somebody knows? Thanks.
Paul

Dear all,

I can't find at the FDA website wether a temperature indication (for storage) of In Vitro Medical devices should be either in degrees ceelcius (°C) or degrees Fahrenheit (°F) or perhaps even both.
Does somebody knows? Thanks.
PaulI don't know that the FDA specifies this, but degrees farenheit is the most common temperature scale used in the USA. I have noticed that some FDA documents specify temperature in degrees C with the degrees F value in parentheses, for example, Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology (http://www.fda.gov/cdrh/ode/gluc.html) states,
Extended exposure to air and light may alter results. It is recommended that the strips be stored in the original capped vial at temperatures below 30 ° C (86 ° F). Avoid exposure to excessive humidity; do not freeze. I have seen device labeling with only degrees C. I have used degrees F with degrees C in parentheses. I don't think you will have problem with any way you do it, as long as it is clear which temperature scale you are using.

:thanks:
Thanks Al,
I will consider your proposal. In my opinion it seems also the best to use both temperature units.
Have a Merry Christmas and a Happy 2006
Paul


I don't know that the FDA specifies this, but degrees farenheit is the most common temperature scale used in the USA. I have noticed that some FDA documents specify temperature in degrees C with the degrees F value in parentheses, for example, Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology (http://www.fda.gov/cdrh/ode/gluc.html) states, I have seen device labeling with only degrees C. I have used degrees F with degrees C in parentheses. I don't think you will have problem with any way you do it, as long as it is clear which temperature scale you are using.