I agree with Ginger, the completion of the forms is just burdensome annoyance, more just a repetition of information from other places in the submission, though valid questions are asked in the Declaration of Conformity form such as if part or all of the standard is used. What I did to get around not sending in the forms was change around Section 9 (I also like Ginger stopped completing them and had 1 out of 4 reviewers send me an RTA because the forms were not there - oh well different reviewers following the checklist !). By the way, if you try to find FDA Form 3654 in their database, it is not there. What I did in Section 9 - Declaration of Conformity and Summary Reports is break out the different types of testing, i.e. sterilisation, labelling, electrical, performance, clinical. Then in each of the sub-sections I created a list of the standards, with title and year/revision, used (recognised consensus or not) along with a statement the entire standard was followed or only indicated the sections used from the standard. Then I had a table under each list with standard number, the FDA recognition number, how the testing was done (internal versus external and listing the external facility), contact info of testing lab, certifications of lab, and then the section where further information could be located, i.e. Section 14 for Sterilization. I took much of the wording from Form 3654 and incorporated directly into Section 9 to get away from using the form. It works well, because I still have a Declaration of Conformity to the standards used either in its entirety or parts of the standard.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Apr-2020 16:07
From: Jo Huang
Subject: DOC vs. general use of FDA consensus standards
If you are referring to the 510(k) submission, DoC is declaring that your testing conforms to the FDA's consensus standards and shows any exceptions or non-applicable criteria in the standard. In my experience, listing of FDA's recognized standards in the Form 3514 should be filled out regardless of whether you use a DoC in the submission or not. It may be redundant, and it's possible that you will not have a DoC for every standard you use, but it is best to still provide the DoC that lists all consensus standards applied in the 3514. If non-recognized standards are used, you can also list them in 3514 and throughout the submission. This is especially true when the bench or biocompatibility testing (whether done in-house or at the outsourced) included any FDA's non-recognized standards. Also, keep in mind that the DoC is to be made per the ISO 17050-1 and ISO 17050-2. Kindly review section 514(c)(1)(B) of the FD&C Act, the final FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, issued on September 14, 2018, and ISO/IEC 17050-1:2004 "Conformity assessment – Supplier's declaration of conformity – Part 1: General requirements" for all necessary components of the DoC. Good luck!
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Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
Original Message:
Sent: 06-Apr-2020 04:41
From: Anonymous Member
Subject: DOC vs. general use of FDA consensus standards
This message was posted by a user wishing to remain anonymous
Hi all,
can you please comment on the difference between DOC vs. general use of consensus standards for FDA submissions?
Is it allowed to issue a DOC, even if some clauses of the standards are N/A?
Also, what are the perks of including a DOC in the submission to the FDA? After all, either way (with and without DOC) test reports are still needed. Is my understanding correct?
Thank you all.