On December 23, 2016, FDA modified the list of standards FDA recognizes for use in pre-market reviews (“FDA Recognized Consensus Standards”). Specifically, this publication announces the following modifications related to consensus standards for anesthesiology; biocompatibility; cardiovascular; quality systems/risk management (QS/RM); general hospital/general plastic surgery (GH/GPS); in vitro diagnostics (IVD); materials; orthopedic; radiology; software/informatics; and sterility:

  • the withdrawal of standards and their replacement by others, if applicable;
  • the correction of errors made by FDA in listing previously recognized standards; and
  • the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

Additionally FDA lists modifications the Agency is making that involve the initial addition of new entries and consensus standards not previously recognized by FDA.

This includes standards related to anesthesiology; biocompatibility; cardiovascular; dental/ear, nose, and throat (ENT); quality systems/risk management (QS/RM); electrical safety/electromagnetic compatibility (ES/EMC); in vitro diagnostics (IVD); materials; orthopedic; physical medicine; and software/informatics.

This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 046” (“Recognition List Number: 046”), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

To access the official FDA publication, please click here.