April 20, 2023

Declarations of Conformity: U.S. FDA vs. Europe

I received a question wondering whether the U.S. FDA mandates Declarations of Conformity (DoC) in the way Europe does, and whether U.S. and EU DoC can be combined into a single document.

In short, no, the US FDA doesn’t, as a general rule, require us to have a DoC in the way of the EU.  But the U.S. FDA does allow the voluntary use of a DoC in certain situations.  For example, in those situations where a 510(k) both a) relies on a voluntary/mandatory consensus standard; and b) the device conforms to all of the requirements of the applied consensus standard.  In other words, if there is any deviation in conformity with the applied consensus standard, then a DoC is not allowed by the FDA.

At one time, such declarations were generally limited to an “Abbreviated 510(k)”.  But nowadays, the way standards are used in Traditional 510(k)s vs. Abbreviated 510(k)s has, in my opinion, become basically the same.

Further evidence of the voluntary nature of such DoCs for the FDA is that FDA may alternatively accept what the agency calls “general use” of consensus standards.  “General use” means situations where the Sponsor decides to apply a consensus standard, yet does not submit a DoC.  Such use could involve either full conformity or partial conformity with the applied standard.

In contrast, every EU MDR / IVDR conformity assessment (except special scenarios like custom-made devices, investigational devices, Article 22 products, etc.) shall include a DoC drawn up in accordance with those European Regulations.

Now, since the aforesaid U.S. DoCs and EU DoCs are both generally modeled after ISO 17050-1 / EN ISO 17050-1 as amended, it certainly wouldn’t be hard to draw up a hybrid DoC that covers both jurisdictions.  But my personal preference is to not mix such declarations.  This is for document succinctness, easier revision control, and to avoid convolution between Europe’s “EN” standards compared to the non-EN versions recognized by the U.S., and also because the basic legislative/statutory reasons/uses of DoCs in the U.S. are fundamentally different than their use for the EU.

And to be sure I haven’t confused anyone, here are a few other clarifying points to consider:

I think that most everyone knows that Annex IV of the EU MDR and IVDR prescribes the exact requirements for an EU MDR/IVDR DoC.  But this post isn’t about how to do an EU MDR/IVDR DoC, nor about what are the precise elements of an EU MDR/IVDR DoC.  Instead, the question at hand is about combining a US DoC with an EU DoC.  Accordingly, for such comparative purposes (U.S. vs. EU), it is, for two reasons, quite germane that an EU MDR/IVDR DoC, is fundamentally modeled after (not the same as; yet modeled after) EN ISO 17050-1.  Specifically:

a) EN ISO 17050-1 is the traditional basis that gave rise to EU MDR/IVDR Annex IV.  For example, the Blue Guide reminds us of that when it states, “…The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity…”. Prior to EU MDR/IVDR Annex IV’s prescription, notified body’s used EN ISO 17050-1 as the basis for auditing MDD DoCs.

b) The U.S. FDA’s stated policy is that, “…To certify conformance with a consensus standard, the submitter must submit a DOC…These elements of a DOC are consistent with ISO/IEC 17050-1…”.

On a related note, I’ve also seen some folks use ‘Declaration of Conformity’ in reference to showing that a product has been inspected and shown to meet device acceptance criteria.  But my experience is that such a document is instead called a Certificate of Conformity (CoC), or Certificate of Analysis (CoA), or something similar.  I’ve not heard of, or seen, such a document being called a ‘Declaration of Conformity’.  To avoid confusion with the more proper conventional and legislative use of ‘Declaration of Conformity’, I would recommend against using ‘Declaration of Conformity’ as the name for a CoC/CoA.