Regulatory Open Forum

Hello everyone,

Is a company required to notify the FDA every time they conduct a Health Risk Assessment (HRA)? The comparison of HHE and HRA on the FDA database doesn't clarify whether or not a company is required to notify the FDA when HRA is conducted.

Thank you, 

Great question! I love these kinds of questions because they distinguish rudimental regulatory affairs (i.e., hanging on for dear life and barely surviving a regulated environment) from sophisticated, deliberate, strategic regulatory (and thus corporate) prosperity and success.

Firms do not need to, nor should they, notify the FDA based solely on the firm having done an HRA (Health Risk Assessment). Likewise, if a firm performs an HHE (Health Hazard Evaluation), this also, in and of itself, does not require notification to the FDA. Instead, the related notification requirements are governed by the criteria for reports of corrections and removals in 21 CFR part 806 (with 21 CFR part 7 supplemental).  As a general rule, FDA notification is required for Class I and Class II recalls.

So what should we make of the comparisons between HRA and HHE? I generally recommend that clients try to model their own use of HRA and HHE after how the FDA itself uses them. Here’s what I mean:

The FDA uses HRA in order to better understand a product that is being "considered for” potential recall. For example, when a device has malfunctioned, HRA helps to predict the potential harm to patients or users.  It also helps FDA begin to gather insights about whether or not other associated actions might be needed, such as public safety notifications.  Accordingly, firms should develop basic risk-based trigger criteria and standard decision-making practices for recognizing when a scenario might necessitate a recall, and then for deciding in due course if recall will or will not be performed.

In contrast, if it is already known that a recall will be performed (such as in the case of a firm’s voluntary recall), then FDA uses HHE for determining the hazards of the product being recalled so as to ultimately assign the proper recall classification. Therefore firms should use HHE to assess and, where applicable, propose the recall classification to FDA (even though FDA has the final say).

Finally, remember that FDA’s process and their form for HRA and HHE are essentially the same; they are just deployed for alternate purposes at different stages of the corresponding deliberations.  Accordingly, firms have a certain degree of flexibility in the details of their corresponding operating procedures, as long as the fundamental intent of “HRA” and “HHE” are properly met.  On that note, I’ve seen too many firms overuse and misuse HRA/HHE, thereby unnecessarily burdening their efficiency, and over-escalating issues that don’t warrant the rigors of HRA/HHE.  Therefore the judicious deployment of HRA/HHE is critical to avoid making difficult problems even worse.

Hope this helps,

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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
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