Saturday 20 September 2014

FDAUDIrule

FDA Unveils Proposed Device Identification System, New Database

The FDA has released a proposed rule that requires most medical devices distributed in the United States carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices (see FDA Amendments Act (FDAAA)). In announcing the proposed system, FDA said the numbers will conform to a standardized, alpha-numeric system of identifying elements, which will be contained within an FDA-run database.

The Associated Press reports the rule will be phased in following a 120 day public comment period. After the rule is finalized regulators plan to phase in the system starting with the highest risk devices. Devices sold over-the-counter at pharmacies and other retailers would not have to carry a code.

The extensive, 164-page proposed rule describes the UDI system and how devices are to be marked.

Some notable excerpts include:

  • Devices intended to be used long-term and separated from its packaging will require the device itself to be labeled with a UDI, including implantable or multi-use medical devices and stand-alone software.
  • All UDI information will need to be submitted to FDA’s proposed database of UDI information, known as the Global Unique Device Identification Database (GUDID).
  • “UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology.”
Pass it on!

4 comments

  • Wendell Thoene | July 4, 2012 at 12:53 pm | Reply

    It would be nice if FDA approved existing reporting and tracking databases already used by manufacturers (like “Pilgrim”) could accommodate UDI.

  • Jim Neville | August 22, 2013 at 12:39 pm | Reply

    Is there consideration for small implanted medical devices that very likely will not fit a barcode like image?
    OR
    does this only apply include ambulatory products?

    • Marc Sanchez | August 22, 2013 at 1:02 pm | Reply

      The proposed rule directly addresses implantable:
      “All implantable devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself. § 801.50.”

      For implantable devices the FDA recommends the following markers:
      “Easily-readable plain-text;
      AIDC technology, or any alternative technology that will allow for identification of the device. Examples include providing the UDI of the device on demand to an external reader or sensor, or making the UDI or a barcode or other representation of the UDI discernible to an x-ray or other imaging system.”

      Feel free to call or e-mail if I can provide further guidance.

Leave a comment

Send comment »

Powered by WordPress. Genius Design by MCS.