Two-Year Medical Device Reporting Window Retained In New FDA Final MDR Guidance

 
• By Shawn M. Schmitt

The US agency has clarified its current thinking on Medical Device Reporting in a new final guidance that allows manufacturers to continue using a so-called “two-year rule” that lets them stop sending MDRs to the agency after 24 months. Overall, the guidance is a roadmap for how firms should structure MDR programs.

US FDA has clarified its current thinking on Medical Device Reporting in a new final guidance that allows manufacturers to continue using a so-called “two-year rule” that lets them stop sending MDRs to the agency if there are no additional product problems after 24 months.

Overall, the guidance released on Nov. 8 is a roadmap for how firms should structure MDR programs to...

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