Medical Device Reporting vs Recall/Correction: What action to take?

L

Laurewen

#1
#1
I have read the regulations and guidances, and I feel like I understand the processes for both individually, I just don't understand how they connect.

I work for a small medical device software company and we were recently informed of a reportable malfunction. The malfunction requires correction, however it is not considered "remedial action to prevent an unreasonable risk of substantial harm to the public health" so it does not require the 5 day remedial action report. I understand the MDR Reporting procedure, but I am unsure if I need to initiate any separate action for the correction.

The regultions on corrections or removals state "no report of correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under parts 803 or 1004 of this chapter." Does this apply to any MDR or only to the 5 day remedial action reports?

This just confuses me because at least in our circumstances I can't imagine having a reportable malfunction that wouldn't require a correction, or a recall that wouldn't require an MDR. I'm not sure how to interpret the regulations/guidance on corrections or removals if a report is not required.

I am assuming that I simply submit the malfunction report and work with the FDA through that channel for any correction we make unless they request otherwise. Can anyone confirm this or let me know if I need to take separate action to communicate with the FDA?
 
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B

biotechreg

#3
#3
if no remedial action to prevent substantial public health risk, and no death possible, and no serious injury possible, then sounds like no report under 21 CFR 803 (MDR), I might also document the reasoning behind why it's not a public health risk etc. by completing a HHE - Health Hazard Evaluation. FDA actually has a form to plagiarise but it's in the OIVD area. You can still use it.
but it sounds like you need to review 21 CFR 7.46 (worst case) or 21 CFR 806. If you are correcting the s/w to remedy a minor violation of the Act - ex. the device failed to meet specs. In 806 it explains when correction is reportable (NOT under 803) and when it is not (Best case). If you are not reporting it, make sure you have complete rationale/justification documented - you're still required to show to inspector. Good luck!
 
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L

Laurewen

#5
#5
Thank you for your help, but I'm still confused on two points:

1) We will be submitting a 30 day report under 21 CFR 803 (not a 5 day). Does the following exemption under 21 CFR 806 apply to both types of report, just the 5 day report, or a request from the FDA to submit a report after reporting under 21 CFR 803?

"no report of correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under parts 803 or 1004 of this chapter."

2) If the report is not required under 21 CFR 806, but we are still making a correction, which parts of the FDA's "Guidance for Industry: Product Recalls, Including Removals and Corrections" should we follow?

-----If you need more background-----
We will be reporting the malfunction under 21 CFR 803. It was borderline on whether we needed to because the decision commitee unanimously agrees that if it recurs it isn't "likely" to result in serious injury (there are already some risk mitigation measures in place and it is reasonably detectable), but it definitely could, and no one on the commitee was willing to classify the chance as "remote," so to be safe we will be reporting.

However, the comittee decided that we don't need to submit a 5 day remedial action report because the remedial action needed to correct the issue isn't necessary to "prevent an unreasonable risk of substantial harm to the public health" as required under 21 CFR 803 (the chance that the malfunction will recur is very remote, if it does it is more likely to not result in serious injury (see above), and the risk the malfunction creates is already inherent to the field)

However, we will still be correcting the software to reduce risk which is required to be reported under 21 CFR 806 (unless we are exempt)
 
B

biotechreg

#6
#6
Thanks for the clarification. From the earlier/first post, it didn't sound like serious injury was possible if the software fault was to reoccur. Now, it does seem like you need:
- a 30 day report from the awareness date under 803.
- I suggest you fill out a HHE (Health hazard evaluation) to quantify the specific severity (the exact harm from uncorrected s/w flaw) and the estimated frequency and, if applicable, the population impacted (ex. seniors, men in their 40's, nurses, etc.) i would have a medical expert (not a Raqa person) sign it.
- my gut reaction is - if you are filing a 30 day report, it sounds like a reportable correction under 806 is NOT required - as long as the CORRECTION is clear in the 30 day report. just so you know what you're getting into, when you fill out the MDR report and submit, sometimes FDA 'redecides' it is a Class III (minor) recall based on the correction details.
- Also be prepared for review of the DHF during next inspection - showing how the reqts specs, RISK ANALYSIS, detailed design, change and regression testing, and s/w validation were updated. Again, best of luck.
 
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