It appears that the FDA has decided to change the criteria for certificate applications -new version of FDA form 3613.
The latest version of this form is posted at http://www.fda.gov/MedicalDevices/D...ce/ImportingandExportingDevices/ucm050521.htm
Please make sure that you review this document before you submitting any new requests.
The latest version of this form is posted at http://www.fda.gov/MedicalDevices/D...ce/ImportingandExportingDevices/ucm050521.htm
Please make sure that you review this document before you submitting any new requests.