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

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.

AsherleeAn abbreviated 510(k) requires summary data reports while a special 510(k) allows a declaration of conformity to consensus standards. Look at, The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance (http://www.fda.gov/cdrh/ode/parad510.html) and Premarket Notification [510(k)] (http://www.fda.gov/cdrh/devadvice/314.html) on the FDA CDRH website. After reviewing the information it will be clear that the answer to your question is no, you may not declare conformity without submitting the reports and data when submitting a traditional 510(k).

Hi Al,

Thanks for the input.
One of the "difficulties" I have in trying to get exact information from specific FDA Guidance Documents, is that you often have to read more than one Guidance Document in order to get the BIG picture and all the relevant facts.

Re biocompatibility: in the explanatory section on Biocompatibility, the FDA Guidance Document on the Format for Traditional and Abbreviated 510(k)’s (dated August 12, 2005), says the following: “If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods.” On the other hand, the ISO 10993-1 standard on biocompatibility does not list PASS/FAIL criteria, only test protocols, so the reviewer might want to see your PASS/FAIL criteria despite your Declaration of Conformity that identical materials were used.

For sterilisation, one also needs to look at FDA Guidance Document
K90-1.

My understanding is that, in principle, a Declaration of Conformity may be appropiate for a Traditioinal 510(k), depending on the standard involved, etc.

Regards,

Asherlee

Hi Al,

Thanks for the input.
One of the "difficulties" I have in trying to get exact information from specific FDA Guidance Documents, is that you often have to read more than one Guidance Document in order to get the BIG picture and all the relevant facts.

Re biocompatibility: in the explanatory section on Biocompatibility, the FDA Guidance Document on the Format for Traditional and Abbreviated 510(k)’s (dated August 12, 2005), says the following: “If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods.” On the other hand, the ISO 10993-1 standard on biocompatibility does not list PASS/FAIL criteria, only test protocols, so the reviewer might want to see your PASS/FAIL criteria despite your Declaration of Conformity that identical materials were used.

For sterilisation, one also needs to look at FDA Guidance Document
K90-1.

My understanding is that, in principle, a Declaration of Conformity may be appropiate for a Traditioinal 510(k), depending on the standard involved, etc.

Regards,

AsherleeIt appears that I was in error and there is validity to what you say. I did some research and found some guidance documents that confirms your understanding.