Does an adverse resulting in serious in injury need to have an health hazard assessment done to evaluate for a recall even though the risk is included in the Risk analysis? What does this form need to include ?
I recommend caution here so you correctly apply the regulations. The manufacturer doesn't decide if a report becomes a recall or determine the recall class. The Center uses the information you submit under Part 806 using their processes under Part 7 to make the recall decision.
In terms of the MDR, you are considering remedial action. If you do take remedial action, then the Part 806 report changes as a result.
You need to follow the process in Part 806. If you are going to make a change to device in the field, then start by expecting it is reportable. Apply the rules for the exceptions to see if any apply. They are improvements, market withdrawals, routine servicing, stock recoveries, and cybersecurity. The application of the exceptions can be confusing, so be sure you apply them correctly. If you take one of the exceptions 806.20 requires a documented review by an independent person.
Assuming it is reportable, then determine the reporting mechanism. I recommend using eSubmitter. Never use the MDR form under Part 806. Even though it is allowed, it doesn't contain all the required information. Electronic products may report under Part 1004.
Notice that Part 806 does not require a health hazard assessment. The team at the Center will generate it in their Part 7 analysis. If you want to use the form on the FDA website that is fine, but it is unlikely that will change your Part 806 decision.
Inclusion in an ISO 14971:2007 risk management file doesn't alter the evaluation of the either the Part 803 or the Part 806 reporting decision. However, the need to report should be part of the post-production information and evaluation in Clause 9 and may lead to a change in the risk control measures and a change in the risk management process.
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