Ever since the FDA rolled out UDI rule, it has faced major hiccups down the road. Increasing concerns of medical device companies over deadlines is one among them. In a recent announcement, FDA yet again informed the compliance dates for certain Class I and Unclassified medical devices have been further extended. These set of devices pose a lower risk to patients, namely manual surgical instruments and mechanical wheelchairs.
Earlier, 24 September 2018 was the FDA set deadline for Class I and unclassified devices to bear a UDI on their labels and packages, apart from mandatory submission of data to Global UDI Database (GUDID). The due date has now shifted to 24 September 2020. In addition, the agency is also said to impose another requirement with respect to Direct Mark for Class I and unclassified devices. The requisite date for Class I and unclassified devices to bear it is 24 September 2022.
The chart below provided by FDA details the new compliance deadlines and label requirements for each device type:
|Type of Device||Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18)||Direct Mark (21 CFR 801.45)|
|Class I devices||September 24, 2020||September 24, 2022|
|Unclassified devices||September 24, 2020||September 24, 2022|
The reason for this two-year delay is rooted to the FDA’s need to rectify few UDI related challenges for higher-risk devices before low-risk devices take over the market. Right from complex policy and technical issues that need a closure, to provide adequate and timely support to those medical device labeler companies who are facing difficulty to meet the set compliance dates, the FDA needs to duly address these challenges in the quickest turn-around-time.
In the meantime, to extend the compliance dates for lower-risk medical devices, FDA says it is planning to issue a guidance document to detail its enforcement discretion policy for labeling, GUDID data submission, standard date formatting and direct mark requirements for the affected devices. It should be noted that this enforcement discretion policy would not apply to class I or unclassified implantable, life-supporting or life-sustaining devices because labelers of these devices must already follow UDI requirements.
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Despite few delays, FDA’s UDI requirements are up and running when it comes to several high-risk devices that includes Class III, and implantable and life-supporting or life-sustaining devices such as artificial heart valves and automated external defibrillators (AEDs). FDA reports claim that its Global UDI Database already contains a whopping 1.4 million records that have been submitted by more than 4,000 medical device labelers.
To streamline UDI labeling and GUDID submissions for your medical devices, it’s imperative to carefully understand the entire process of development, validation, design and submission of requirements. Keep pace with UDI compliance standards.