The FDA has 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 standards for biocompatibility 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 biocompatibility.

 This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 044” (“Recognition List Number: 044”), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

To View or Download the US Federal Register Notice, Click Here.