Nov 10, 2011

The US Food and Drug Administration has extended its medical device modifications requiring new 510(k) submissions.

According to the FDA, leaving the guidance’s comment period open for a longer period of time will allow more industry participants to provide feedback on the agency’s proposal. The guidance lists manufacturing changes, labeling changes, technology or performance specification changes and material changes as requiring manufacturers to file new 510(k) applications to determine whether any such changes have impacted the devices’ safety or effectiveness.


  • Stewart Eisenhart