Note however that in the event that a single change or series of changes to an existing device crosses the threshold for filing of a product-change 510(k), standards revisions may become applicable to the device. This is murky territory, since the re-examination process is not rigorously guided. The standards compliance section of the 510(k) is an obvious problem area, but other problems may exist as well. My understanding is that a risk analysis filed with a product-change 510(k) will have to analyze safety and effectiveness in regard to current Recognized Consensus Standards, whether or not those standards were applied to the original design.
Also note that this area is ripe for radical change if/when harmonization goes forward. There is certain to have to be a negotiation between FDA and EU, for instance, regarding who will change what requirements to achieve harmonization, and I think the general expectation is that each side will revise a few areas. My guess is that this is an area where the FDA will willingly adopt the MDD approach. I'd further expect that starting soon, such changes will begin to be supposedly-unilaterally adopted by FDA one at a time, based on their knowledge of behind-the-scenes discussions, so as to diminish the mass of changes that will occur at the time of eventual official harmonization.