A
To all,
I know that in a submittal for an ABBREVIATED 510(k), I can submit a Declaration of Conformity or compliance with a FDA recognized consensus standard.
My question is whether I can submit such a Declaration of Conformity in a TRADITIONAL 510(k) submittal in place of a full test report and accompanying test data; for example, can I submit a Declaration of Conformity for a medical device that was sterilized with EO, or for a device that was tested for biocompatibility, in place of the full test report?
In the case of sterilization, the device for which a 510(k) is being applied for, is sterilized in the same way (same method) as the predicate device. In the case of biocompatibility, the device for which a 510(k) is being applied for, is made of the same materials as the predicate device.
Thanks for the input.
Asherlee
I know that in a submittal for an ABBREVIATED 510(k), I can submit a Declaration of Conformity or compliance with a FDA recognized consensus standard.
My question is whether I can submit such a Declaration of Conformity in a TRADITIONAL 510(k) submittal in place of a full test report and accompanying test data; for example, can I submit a Declaration of Conformity for a medical device that was sterilized with EO, or for a device that was tested for biocompatibility, in place of the full test report?
In the case of sterilization, the device for which a 510(k) is being applied for, is sterilized in the same way (same method) as the predicate device. In the case of biocompatibility, the device for which a 510(k) is being applied for, is made of the same materials as the predicate device.
Thanks for the input.
Asherlee