Warning letters for lack of MDR procedures

The FDA wrote warning letters to 16 laser eye centers (probably all under the same ownership) throughout the country for the lack of written MDR procedures. The MDR procedures are part of 21CFR803, whereas the Quality System Regulation (QSR) is codified in 21CFR820; that might be a reason that the MDR procedures are often overlooked. In my experience, the FDA is now actively checking for those procedures, but a few years ago they were not that keen. So make sure that you have these MDR procedures!