Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio
I've read that article and it really doesn't say too much beyond a basic overview
In the context of managing device risk, the interesting point in the new draft guidance is that a "significant change in the device's risk profile" is likely to necessitate a new 510(k) submission. It's interesting to note that in that context the FDA considers a significant change in effectiveness a risk that should be evaluated in the decision process, and not only a significant change in safety (ie the traditional view of risk). ISO 14971 is mentioned several times as a preferred / recommended framework for assessing device risk, but it's certainly not the only acceptable way.
I've read that article and it really doesn't say too much beyond a basic overview
In the context of managing device risk, the interesting point in the new draft guidance is that a "significant change in the device's risk profile" is likely to necessitate a new 510(k) submission. It's interesting to note that in that context the FDA considers a significant change in effectiveness a risk that should be evaluated in the decision process, and not only a significant change in safety (ie the traditional view of risk). ISO 14971 is mentioned several times as a preferred / recommended framework for assessing device risk, but it's certainly not the only acceptable way.