The deadline is fast approaching.  If you are a Class 1 medical device manufacturer, September 24, 2020 is a date that most likely has been circled on your calendar for quite some time.  And while September might feel distant, I will caution that the amount of time and effort to prepare for compliance with the GUDID regulation is frequently underestimated.  The time to act is now!

In order to prepare for your GUDID submission, there are many matters that must be addressed.

In order to clear up any confusion, I have provided the four steps your organization can follow to meet the upcoming September deadline.

Prepare. Capture. Manage. Distribute.

Step 1: Prepare

For manufacturers it is critical to PREPARE by defining a UDI strategy and process.

Step 2: Capture

Manufacturers must CAPTURE their data.  This step involves determining which products are impacted, finding the proper data needed, and evaluating the accuracy and completeness of this data.

Step 3: Manage

MANAGING the data.  Organizations must aggregate the data into one “source of truth” and most importantly, formulate a process to manage and update product information as necessary.  Many do not realize this is not a one-and-done project, rather, it is an ongoing function that must be handled effectively.  Because of these reasons, the complexity of managing data is often underestimated.

Step 4: Distribute

Finally, the question remains: how will you DISTRIBUTE your data to the FDA and who within your organization will be responsible for this effort?  Deciding what is right for your organization is not as simple as it might sound.

The great news is, 1WorldSync has a team of experts who can help your business prepare your medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.

1WorldSync is the leading expert for product content solutions, serving more than 13,000 organizations around the globe and managing over 3.2 million products in the healthcare sector alone.  To date, 1WorldSync has successfully submitted 40,000+ UDI’s to the FDA GUDID.  We are experts and have a seamless and proven process to assist your organization.

To discuss how 1WorldSync can help with your regulatory compliance needs contact me at tmarshall@1worldsync.com or visit https://1worldsync.com/industries/healthcare/unique-device-identification/