Is there any scenario in which you can put "aid in diagnosis" claim in your IFU without showing "new" clinical performance data?

Mike W

Starting to get Involved
Context.
I currently have an FDA approved and CE marked quantitative assay for an analyte to measure an endogenous steroid hormone in both men and women. (its progesterone). This assay was developed in the late 90's. in the IFU for this assay (USA), it says that this assay is used for the quant. detection of said analyte. Thats it. It is an exempt assay.

Forward to today,
  • Id like to "update" the assay by changing out the type of antibodies it uses, but still use the same technology (elisa kit)
  • Im told that we "need" to add a claim in the intended use that says "used as an AID in diagnosis of several disorders" (its very non-specific and other competitors for this analyte say the same thing).
My question,
  • Since we need to tack on the language that this assay is used as an AID in dx for several disorders etc., do we need to show clinical performance data via a clinical study?
  • I am under the impression we are only required to do a NEW reference interval study for a healthy population.

I am happy to provide more context if I am missing key pieces of information that would help the sub-forum tackle my question.
thanks so much,.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
What does "Im told we need to add" part mean. Are you being ordered to do this by marketing?
 

Mike W

Starting to get Involved
What does "Im told we need to add" part mean. Are you being ordered to do this by marketing?
Ha, thank you. yes (we were "told" that to be competitive we needed to include the language 'aid in diagnosis") but also, since we also plan to get CE mark again for this updated assay, and because of new rules of IVDR (i believe) , reusing the language in the previous IFU would not be suitable, it cant just say simply "for quant measurement of X". language must be more specific...
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
CE under IVDD? Or IVDR? What is the waiting list for that? Seems high.
 

Parul Chansoria

Regulatory and Quality Expert
This is a good topic for discussion @Mike W. Some thoughts below:

  • It is true that the new In Vitro Diagnostic Regulation (IVDR), lays an emphasis on providing more specific and accurate language in the indication for use.
  • Earlier the indication that the product is used for the "quantitative detection of an analyte" would work, but per the IVDR now, the intent is to see how this fits in the complete clinical workflow and assess how this quantitative data will help in clinical decision making process.
  • In case of IVDs the quantitative data would mostly help in diagnosis of a wide variety of conditions that could affect these hormones and that is why not specifying the condition in the "indication for use" would work.
  • The core technology of the product and its mechanism of action is based around precise and accurate quantitative detection, I would agree that a NEW reference interval study for a healthy population would work.
  • However, whatever clinical study you plan to do there should be a solid scientific justification as to why that study is going to be sufficient.
  • I would also include data from published literature (if any) for this product, post market data for the previously marketed quantitative detection (as the basic principle is still the same, only difference is we fit it in the overall clinical decision making process), similar products on the market and drawing similarities to those, previously conducted studies, if any, showcasing no MAUDE database issues, if applicable, established history and usage of the product and its technology.
  • With all these under your belt, you may have to do a study with much smaller sample size.
  • It would be good to utilise the various applicable standards, like ISO 20916:2019, etc.
Hope this helps.
Best,
Parul Chansoria
 
Top Bottom