Hello Anon,
It appears the content of Section 9 for Declaration of Conformity and Summary Reports either was not available or does not have the correct information. The answer to your questions might be a bit challenging to address without seeing the source material and how the submission content was provided to the US FDA. The FDA Form 3514 was updated to correspond to content which should be included in Section 9; within this section there would be a summary of the recognised standards (and non-recognised standards) which were used or claiming compliance. In this section there should be a declaration and summary of how the standard was used such as in its entirety or partial sections, external testing performed, accreditation, if the current version was not used, etc. If you have looked through the guidance document, this information then needs to be summarised in a Section 9 of the submission (this is referring to the current 20 section layout of a 510(k) and not an eSubmission version). As you can see on FDA Form 3514 there is a "location" where the information of the standard can be located. I usually also create a cross-matrix or reference linkages in Section 9 to any other section of where a standard is used, e.g. ISO 11135 for sterilisation would be in Section 14 (and can be as specific as possible such as Section 14, sub-section 14.2).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Oct-2022 05:42
From: Anonymous Member
Subject: General use of a consensus standards RTA Checklist Hold
This message was posted by a user wishing to remain anonymous
I submitted a 510K and we received the following response during the RTA check.
Comment:
The submission utilizes voluntary consensus standards. However, the submission is missing the following information.
- a) The submission cites FDA-recognized voluntary consensus standards.
- i) Though, the submission does not include a Declaration of Conformity (DOC) as outlined in FDA's guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarketsubmissions- medical-devices. NOR If citing general use of a standard as noted in FDA's guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices," the submission does not include a basis of such use as included, along with the underlying information or data that supports how the standard was used.
Could you please advise on what the FDA would accept for the client to include a basis of such standard use as included, along with the underlying information or data that supports how the standard was used.
- Should this be an appendix to the form 3514 outlining the information required to support how each standard was used?
- What type of detail is required in this supporting material?
I have reviewed the guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices | FDA, however I still require further feedback on how best to respond.
I appreciate any feedback on this topic.
Thanks!