FDA requirements for risk analysis

GiuliaGe

Starting to get Involved
Hi everyone! I am quite new in the field of regulatory affairs and I am facing the problem of QMS gap analysis to get FDA compliance for submission.

The company I work for produces active medical devices in the field of hemodinamics.

I have heard from colleagues that one of the requirements of the medical device risk management process for FDA is that the risk analysis be validated by a clinical physician in the field based in the US (our company is based in europe).
could you confirm or deny this requirement and possibly share the reference in the FDA guidelines or 21 CFR of this requirement that mention it?

Thank You very much for sharing

Giulia
 

Tidge

Trusted Information Resource
21 CFR 820 predates the current "state of the art" for risk management of medical devices (14971), I encourage you to read the Preamble to 21 CFR 820. 14971 is a consensus standard recognized by the FDA.

The phrasing of this question leaves a LOT of room for discussion:
I have heard from colleagues that one of the requirements of the medical device risk management process for FDA is that the risk analysis be validated by a clinical physician in the field based in the US (our company is based in europe). could you confirm or deny this requirement and possibly share the reference in the FDA guidelines or 21 CFR of this requirement that mention it?

I'm not at all aware of any legal requirement in the USA, but given nationalistic tendencies I wouldn't be shocked if there are some such requirements (for any country). With that disclaimer...

0.0) The Risk Management process for medical devices covers the entire lifecycle of a device, from early development through production through retirement. Clinical involvement is important at every step.

0.1) I am going to assume that the reference to "validation" in the question is specifically referring to summative user validation of a finished design prior to going on market. (link to FDA Guidance on Human Factors considerations) If this is NOT what is meant, the question is not focused enough to get anything like a direct answer. (There are too many rabbit holes to go down)

The geographical location of appropriate clinical folks is less important than the idea that the manufacturer has well-defined the class(es) of users(*1), and that the summative validation appropriately challenges the design and use of the finished good. A peculiar example: If the medical device's interface was designed using symbols only used in a certain region, it would not be appropriate to claim that the UI was validated for use in other regions.

(*1) If the class of users is rather narrow and all the users in that class have the same training (i.e. it isn't different region-to-region) I would see no reason to require a geographically heterogeneous distribution of users in a summative validation. Mileage varies of course with respect to translations.
 

yodon

Leader
Super Moderator
Just to add on to the excellent post provided by @Tidge, it's been my experience that reviewers (FDA and CE) now expect to see participation of someone with clinical expertise. I think, historically, many Risk Files have been done solely by engineering and the reviewers are saying that they don't have the clinical expertise to know the harms and/or severity. I would suggest that such expertise needs to be involved in the decision of overall residual risk acceptability. (I require that our customers have a clinical expert sign off on the risk report, by the way.)

The bit about being based in the US, to me, is off.

Side note (maybe a bit off topic): there *is* an expectation when doing clinical trials, the study subjects need to be in the US. There's a guidance on that somewhere.
 
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