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FDA Extends UDI Compliance Date for Lenses

The U.S. Food and Drug Administration (FDA) granted a one year extension of the Unique Device Identifier (UDI) labeling requirements compliance date for most contact and intraocular lens labelers.  The FDA’s final rule regarding the Unique Device Identification System states that class III medical devices must comply to UDI labeling requirements by September 24, 2014, but the compliance date is now September 24, 2015 for the following class III devices (product codes are in bold):

  • Rigid Gas Permeable Contact Lenses (extended wear)  MWL
  • Orthokeratology Contact Lenses (overnight)  NUU
  • Soft (hydrolic) Contact Lenses (extended wear)  LPM
  • Intraocular lens (IOL)  HQL
  • Multifocal Intraocular Lens  MFK
  • Accommodative Intraocular Lens  NAA
  • Toric Optics Intraocular Lens  MJP
  • Phakic Intraocular Lens  MTA
  • Iris Reconstruction Lens   NIZ

FDA extended the compliance period because of the enormous amount of Global Unique Device Identification Database (GUDID) submissions that will result from lens labelers, and because many of these submissions will be nearly identical. The extension gives FDA time to work with lens labelers to develop an efficient approach to getting the information into the GUDID.

For any questions about FDA UDI regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.