FREE consultation 9871231133

Draft Guidance on Unique Device Identification for Direct Marking of Medical devices

Draft Guidance on Unique Device Identification for Direct Marking of Medical devices

FDA has released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”. The document is intended to help medical device labelers and FDA staff in understanding the FDA’s requirements for direct marking of devices for unique device identification (UDI) purposes.

A unique device identifier (UDI) is required to be directly marked on a device, if the device is required to bear a UDI on its label, and is to be used more than once and reprocessed before each use. Such devices are typically intended to be used for months or years. Because they are intended to be reprocessed and reused, they will likely be separated from their original labels or device packages bearing UDIs. Directly marking these devices with a UDI best assures adequate identification of such devices through distribution and use.

The final UDI compliance dates are:

1. for Class I, class II and unclassified implantable, life-sustaining or life-supporting devices have a UDI labeling and GUDID submission compliance date of September 24, 2015.

2. All life-sustaining or life-supporting devices have a UDI direct mark compliance date of September 24, 2015. Please note: Implants are not required to be directly marked.

detail information about the Unique Device Identification (UDI) System, can be found on FDA’s UDI webpage..

Testimonials

  • I would like to thank entire team of Meddevices for your assistance and guidance in obtaining ISO & CE certification. Your help will be instrumental in our continued growth & success.

    Arul Pragyasam
  • Thank you Meddevices! They have tackled all aspects of my CE case in a very short period of time. They are by far the best team I have worked with..

    Karen Roberston
  • I wouldn’t think of facing an FDA audit without Meddevices’s Assistance..

    Gerhard frick
  • I deeply appreciate the outstanding service that Meddevices have provided us over the last ten years..

    Gregony Denton

Newsletter

Company Info

MED DEVICES LIFESCIENCES LIMITED was formed to provide medical device manufacturers world-wide with flexible and well adjusted service packages to assist its clients to comply with EU & US legislation .

Med Devices 123 fifth Avenue
New York, NY 10160
Ph: +19142942185
Email: info@meddevices.com
                        

Quick Form






2015 MedDevices. All Rights Reserved