There has been some updates to the 510(k) information in response to the IOM report to clarify that FDA includes in its 510(k) review the safety and effectiveness of the medical device, although no significant changes were made to the 510(k) process itself.

FDA has issued a memorandum (link below) in January clarifying that its review of the medical device in the 510(k) program involves a substantial review of safety and effectiveness (pg 44).
https://www.regulations.gov/document?D=FDA-2016-N-1149-0040

The current information on FDA website about premarket notification states “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.”
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

In addition, FDA has issued a guidance document in August 2016 “Deciding when to submit a 510(k) for a change to an existing device” which emphasizes any change or modification that could significantly affect safety and effectiveness of the device requires new 510(k) submission.
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf