UDI Compliance Update

by | Jul 2, 2020 | FDA, Medical Devices, Requirements, UDI

The UDI Rule requires a device to bear a UDI on its label and packages. Special labeling requirements apply to standalone software regulated as a device. The UDI Rule also requires that data pertaining to the key characteristics of each device required to bear a UDI be submitted to FDA’s GUDID.1

FDA’s Unique Device Identification rule was designed to identify devices through its distribution and use. A phased implementation strategy is being followed, which began in September 2014 through September 2020.1

The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices were:1

  • September 24, 2018, for the following requirements:

o Standard date formatting

o Labeling, and

o Global Unique Device Identification Database (GUDID) data submission and

  • September 24, 2020, for direct mark requirements.

FDA realizes that because of the COVID-19 crisis, the industry is scrambling to meet the supply shortages, and hence does not intend to enforce the standard date formatting, UDI labeling and GUDID data submission requirements prior to September 24, 2022.1

The compliance date for direct marking of class III and class II non-sterile devices was Sept 24, 2016 and September 24, 2018, respectively. The manufacturers were not required to comply with the UDI requirements until 3 years after the labeling compliance date. However, in its latest guidance document, FDA mentions that it does not intend to enforce UDI Direct Mark requirements when the UDI can be obtained from other information which is directly marked on the device.1

The direct mark compliance dates for class I and unclassified devices is Sept 24, 2020. However, due to the pandemic and after realizing the cost to remediate existing devices in inventory to add a direct mark, FDA does not intend to enforce UDI direct mark requirements prior to Sept 24, 2022.1

Additionally, after September 24, 2022, FDA does not intend to enforce UDI direct mark requirements for finished class I and unclassified devices,  that were manufactured and labeled prior to September 24, 2022, and that remain in inventory, when the device’s UDI can be derived from other information directly marked on the device.1

Need help with your UDI labeling? Call us today at 248-987-4497 or email us at info@emmainternational.com.

1FDA (July 2020) Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking retrieved on 07/01/2020 from https://www.fda.gov/media/110564/download


Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This