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Has anyone been through an International EPRC inspection by FDA? My parent company, based on Germany, will undergo this kind of inspection by FDA in September. Interestingly, they’ve already completed their MDSAP Audit. Apart from the following page, I haven’t been able to find much about the requirements ...

You can request redacted copies of 510(k)s via the Freedom of Information Act. FOIA Request My recollection is that FDA reviews the firm's redactions and will make them public if they're not permitted to keep that information confidential. ------------------------------ Mike Loiterman RAC ...

Just to reiterate what others have said, I would simply explain to FDA why you cannot implement your original commitment in addition to also providing reasonable justification and explanation for how your alternative would similarly resolve their observation. Irrespective of any positive or negative ...

If the product code supporting the desired indications says that the device is Class I and 510(k) exempt. ------------------------------ Mike Loiterman Cell: 630-302-4944 Email: mike@ascendency.net

Please add me to the virtual RAC study group as well. I've seen a lot of requests for this, but is anything actually happening with this? ------------------------------------------- Mike Loiterman -------------------------------------------