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Beth Foster

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United States

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1 to 5 of 6 total

RE: Cleaning Validation

Posted By Beth Foster 10-Apr-2020 09:13
Found In Egroup: Regulatory Open Forum \ view thread
We are going through cleaning validation.  Our device is a non-critical device with limited patient contact.  The testing lab that we are using cites AAMI-ST98, Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices. This is ...

RE: FDA Review times and COVID-19

Posted By Beth Foster 24-Mar-2020 08:54
Found In Egroup: Regulatory Open Forum \ view thread
Hi Julie, Please see the attached letter from FDA.  It is an industry wide extension for all marketing reviews. ------------------------------ Beth Foster Regulatory Affairs Manager Miami Lakes FL United States ------------------------------

RE: FDA Review times and COVID-19

Posted By Beth Foster 24-Mar-2020 04:53
Found In Library: Regulatory Open Forum

RE: FDA Review times and COVID-19

Posted By Beth Foster 24-Mar-2020 04:45
Found In Egroup: Regulatory Open Forum \ view thread
Never mind - I just saw the Letter to Industry granting anyone that has a marketing application currently on hold gets an extra 60 days. ------------------------------ Beth Foster Regulatory Affairs Manager Miami Lakes FL United States ------------------------------

RE: FDA Review times and COVID-19

Posted By Beth Foster 24-Mar-2020 04:43
Found In Egroup: Regulatory Open Forum \ view thread
We asked for an extension for our AI Response due to a delay in our testing.  We just got granted an extra 60 days.  Did anyone else receive information on extensions? ------------------------------ Beth Foster Regulatory Affairs Manager Miami Lakes FL United States ------------------------- ...