Message Image  

Latest Discussions

  • FDA typically does not respond to FDA-483 responses from manufacturers. They do respond to Warning Letter responses that have been filed on time. If they do not get a timely response from either FDA-483 or Warning Letter or they are not happy with the Warning Letter response, they may respond with a Warning Letter at some unknown time. You can...

  • I received another report of 5 years since the last inspection, plus an observation that FDA's budget for inspection of Class I devices is $0. And Ginger is not alone in thinking that there may be some geographical differences in frequency of inspections, which reflect differences in FDA resources available from district to district around the country....

  • Can anyone point me to labeling requirement for Class 1 devices, both on the device and the accompanying paperwork, for USA and EU? ------------------------------ Samir Shah Miami FL United States

Most Active Members