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HI everyone, I'm planning for the summer exam as well.  Has anyone identified any good study or practice exam resources?  I'm using the RAPS toolbox but would love to have more than one practice exam to work with. thanks, Kathleen ------------------------------ Kathleen Aras SUGAR LAND TX United States ------------------------------

Jennifer, Thank you for the detailed suggestions regarding file management and tips for organizing our submission and other regulatory associated records.  Your tip on "one person should be responsible for filing" and keeping a consistent naming convention are well appreciated.  We want to build a working approach that is scaleable with data that is ...

This message was posted by a user wishing to remain anonymous Hello,  I wonder how to understand the need for a new 510 K (significant change) in case of a change in material coating for a surgical device.  If we would change the coating material of a class II disposable surgical device by an other coating material known to be also biocompatible, medical ...

Hello Anon, Well first it is strange you already had a Q-Submission meeting with FDA and told you to then do a 513(g) submission.  I am surprised they just did not confirm or tell you the classification regulation number and/or Product Code as part of the meeting.  Though hard to say not being there and not knowing your device. To answer your question, ...

Blood glucose meters would fall in the category requiring direct marking.  Think about it from a user stand point.  I get my first blood glucose meter, open the box, read the instructions (haha), start using my meter, throw the box away, throw the instructions away.  Two years in the future something happens with the device, who do I call to get it ...