An Example of a Risk Analysis Report for a Class II Medical Device (Oxygen Mask)

A

aAlexanderL

#1
I apologize for this question, as it is pretty basic. We are a new start-up with only 3 employees, but with 4 510(k) applications pending with FDA for new device designs. FDA has issued a letter for additional information, asking for a risk analysis document. The device, while Class II, is pretty basic and low tech (i.e. an oxygen mask). While we have experience with medical product design, engineering and manufacturing. None of us are too keen on risk analysis. Does anyone have a basic format of a document for risk analysis for a medical device? I understand general risk management principles, but with FDA, so much seems to be their expectation of seeing data in a particular format. There must be a standard report form for simple risk analysis. I want to comply with FDA's request with a document that looks like what they are used to seeing. If you can help, please email a copy of a sample report. I just need a guideline or format of sorts. Thank you.
 
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Michael Malis

Quite Involved in Discussions
#2
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

aAlexanderL,

Each product is different and you need to apply ISO 14971 (Risk Analysis) appropriate to your product. What FDA would like to see is the use of any (FMEA, Hazard Analysis, etc. ) technique to evaluate the appropriate risks for your product. Attachments to ISO 14971 provide guidance and templates.

Hope this helps,
Mike
 
A

aAlexanderL

#3
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Yes, that does help. I have the ISO 14971 document, but will need to see if I can locate the attachments or appendix. I didn't realize they included templates in the attachment.
 
A

aAlexanderL

#5
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Thanks for taking the time to reply. I really appreciate the help. I have reviewed ISO 14971, and just read over (albeit a bit quickly) the attachments. I understand everything I am reading. The problem is still the same. FDA is accustomed to seeing risk analysis presented in a standard format. If I could just find a link to a sample, or an example, for any medical device, I would feel comfortable. I want to furnish FDA with something that has the look and format of what they are used to seeing.
 
A

aAlexanderL

#6
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

That is helpful also. The essential requirements checklist is in addition to the risk analysis document I suppose.
 

Michael Malis

Quite Involved in Discussions
#7
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

You can use checklist as a guide to make sure that all appropriate risk categories are covered... At the end, FDA want to make sure that YOU understand and address all appropriate risks. Define what is the appropriate Risk for your device in numbers and stay the course (i.e. don't show that total risk for XYZ is unacceptable AND you did not do anything to make it acceptable)!
 
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A

aAlexanderL

#8
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

All I can say is "thank you" again. Was lucky to stumble across this forum. Never knew it existed. You've been very helpful.
 

SteveK

Trusted Information Resource
#10
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

I apologize for this question, as it is pretty basic. We are a new start-up with only 3 employees, but with 4 510(k) applications pending with FDA for new device designs. FDA has issued a letter for additional information, asking for a risk analysis document. The device, while Class II, is pretty basic and low tech (i.e. an oxygen mask). While we have experience with medical product design, engineering and manufacturing. None of us are too keen on risk analysis. Does anyone have a basic format of a document for risk analysis for a medical device? I understand general risk management principles, but with FDA, so much seems to be their expectation of seeing data in a particular format. There must be a standard report form for simple risk analysis. I want to comply with FDA's request with a document that looks like what they are used to seeing. If you can help, please email a copy of a sample report. I just need a guideline or format of sorts. Thank you.
Hi Alexander,

Hopefully the attached report is the type of thing you are after. Other than Foreseeable Risks (F) the may also be Known (K) - for example I know that there has been a recent device alert/recall for oxygen masks because of leakage of a substance (plastizier?) over time.

Steve
 

Attachments

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M An example of risk analysis of class I MD ISO 14971 - Medical Device Risk Management 36
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D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
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M Example of a Risk Assessement File for Medical Device Other ISO and International Standards and European Regulations 2
S Aspect vs. Impact and Hazard vs. Risk - Short/clear explanation & example Miscellaneous Environmental Standards and EMS Related Discussions 11
D AS9100C Risk Management Procedure Example AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 111
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