Tag: UDI Submission

UDI REQUIREMENT FOR CLASS I MEDICAL DEVICES

The Unique Device Identification (UDI) system is a globally recognized system for identifying and tracking medical devices throughout their distribution and use. It was established by the US Food and Drug Administration (FDA) to enhance patient safety and improve the efficiency of medical device recalls.

For class 1 medical devices, which are considered low risk devices, the UDI requirements are more flexible than for higher risk devices. Class 1 devices are exempt from the requirement to include a UDI on the device label if they are exempt from GMP regulations.

FDA has categorized Class 1 devices in two categories.

  1. Class 1 devices that are considered as consumer health products.
  2. Class 1 devices that are not considered as consumer health products.

Class 1 devices that are considered as consumer health products are the devices that pose the lowest risk of which many are 510(k)-exempt devices are sold directly to consumers over-the-counter in retail and online stores. Since these devices pose the lowest risk, FDA does not intend to enforce GUDID submission requirements under consumer health products.

Class 1 devices that are not considered as consumer health products are the devices that are typically used in healthcare settings and are often subject to additional regulatory controls, such as 510k submission. Submission of UDI for these devices will be helpful in reducing medical errors and simplify the integration of device use information into data systems.

Below are the compliance dates for class I medical devices.

Device Type Compliance Date
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI September 24, 2022
Class I and unclassified devices, other than I/LS/LS devices September 24, 2022
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI December 8, 2022

The UDI for class 1 medical devices must be in a human-readable format and a machine-readable format, such as a barcode or RFID tag. The UDI must also be submitted to the FDA’s Global Unique Device Identification Database (GUDID), which is a publicly accessible database that contains information on medical devices.

The UDI system helps to ensure the safety and effectiveness of medical devices by enabling more accurate tracking and monitoring of these products throughout their lifecycle.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.

Sudha S

Regulatory Consultant

WWW.fdahelp.us

Email: Office@libertymanagement.us

UNIQUE DEVICE IDENTIFICATION (UDI)

FDA has released a final rule under which all medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device which is used to identify the devices through their distribution and usage of it. UDIs should be on the device labels in both a human-readable format and a machine-readable format (e.g., a barcode) unless the rule provides for an exception or alternative. The UDI should be marked directly on the devices that are intended for more than one use and has to be reprocessed before each use.

A UDI consists two parts, Device Identifier (DI) and Product Identifier (PI), where

Device Identifier (DI) is a mandatory, fixed portion of a UDI which identifies the specific version or model of a device and its labeler. Labeler has to apply for New DI if there is any change in version or model of the device.

Product Identifier (PI) which is a conditional and variable portion of a UDI is required to identify the lot or batch number of a specific device , serial number, expiration date, date of manufacture and the  distinct identification code(If applicable). PI will change for each lot or batch.

FDA has accredited the following agencies in assignment of UDIs according to the UDI regulations.

  1. GSI – http://www.gs1.org/
  2. Health Industry Business Communications Council (HIBCC) – http://www.hibcc.org/
  3. International Council for Commonality in Blood Banking Automation (ICCBBA – http://www.iccbba.org

Each issuing agency has a unique device identifier (UDI) format that was assessed and approved by FDA as part of its process for accrediting issuing agencies. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation.

Device labelers are required to submit information about each device to FDA’s Global Unique Device Identification Database (GUDID), where the public can search and download information from GUDID at AccessGUDID.  GUDID has a standard set of basic elements for each device with a UDI, which contains only DI that helps to get the device information in the database.  Product Identifiers (PI) are not part of GUDID

Compliance Dates issued by FDA in conjunction with UDI Final Rule are

  1. Class III medical devices which includes stand –alone software  – September 24, 2014
  2. Implantable, life supporting and life sustaining devices which includes stand-along software – September 24, 2015
  3. Class III reusable devices that are required to have UDI on the device itself, Class II devices – September 24, 2016
  4. Class II reusable devices that are required to have UDI on the device itself, Class I which includes stand-alone software and Unclassified devices – September 24, 2018
  5. Class I reusable devices that are required to have UDI on the device itself – September 24, 2020
  6. For Class I and unclassified devices manufactured and labeled on or after September 24, 2018 – September 24, 2022
  7. For Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 – September 24 , 2022

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

www.fdahelp.us