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.