The present FDA guidance is subject to immediate implementation without the usual procedure of public consultations required under the general rule. However, industry representatives are still allowed to submit their comments and suggestions as they will be taken into consideration by the authority.
Regulatory Background
The Unique Device Identification system is intended to identify medical devices allowed to be placed on the US market at each step of their lifecycle. The particular requirements on UDIs are closely related to the risk-based classification of medical devices.
According to the FDA guidance, the following compliance dates should be applied for:
- Standard date formatting (regulation 21 CFR 801.18) – September 24, 2018;
- Labeling (21 CFR 801.20, 21 CFR 801.50) – September 24, 2018;
- Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300) – September 24, 2018;
- Direct mark requirements (21 CFR 801.45).
The FDA also emphasizes that the aforementioned rules should be applied to non-sterile Class I and unclassified medical devices manufactured and labeled prior to September 24, 2020. It should not be applied for implantable, life-supporting, or life-sustaining medical devices.
The scope of the document covers requirements related to the direct mark compliance policy for Class III, life-supporting and life-sustaining medical devices, and also for non-sterile Class II medical devices if such a device is being produced and labeled prior to the appropriate direct mark compliance date.
US Unique Device Identification Requirements
The initial rule on the UDI system was published by the FDA earlier on September 24, 2013. According to the aforementioned document, the actual implementation of the system is based on several compliance dates depending on the class of the medical device under the risk-based classification. All compliance dates fall within a range from September 24, 2014, to September 24, 2020.
In accordance with the general requirements for unique device identification, the medical device allowed to be marketed and used in the USA should bear a UDI on its label and packaging (excluding certain cases when the appropriate exception should be applied) i.e. if software intended for medical purposes is subject to regulation as a medical device. The aforementioned requirements also provide that the most important information related to the medical device and its features should be uploaded to the GUDID. The labeling of medical devices certain dates, in general, should be provided in accordance with the standard format.
The compliance date is defined as a particular date prior to which the medical device manufacturer shall ensure compliance with the appropriate requirement. If the particular medical device is required to be marked with the UDI and is intended by its manufacturer to be used multiple times (including reprocessing between users), such a device should be directly marked with a UDI in accordance with the regulation 21 CFR 801.45.
The FDA also emphasizes the importance of connections and data exchange between various sources. This includes all elements of the supply chain, records stored in the electronic form, and healthcare registers. To ensure efficient communication, completeness, and accuracy of the information, the UDI data should meet the highest quality requirements.
The initial guidance on the UDIs for Class I and unclassified medical devices was issued by the Agency in January 2018. The guidance introduced basic requirements and rules related to UDIs and the way they should be implemented. After receiving numerous submissions, the FDA decided to expand the scope of the guidance to higher-risk medical devices. The current extension of the regulatory framework to other classes of medical devices is intended to improve the level of public health protection. The FDA also mentions that certain regulating flexibilities would be available for the medical device manufacturers facing difficulties due to the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.”
The authority also describes a special approach to be applied to medical devices subject to direct marking: if such devices have been already manufactured before the requirement on direct marking was implemented, the manufacturer will be allowed to place a direct mark only to future lots since adding such marks to already existing devices could result in additional expenses that could be significant. The FDA states that such flexibility has been introduced in order to assist medical device manufacturing in maintaining compliance with the applicable direct marking requirements. This ensures the availability of medical devices and aims to avoid potential shortages in supply caused by regulatory issues. The FDA finds such rules suitable due to the low risk to public health associated with the actual requirement waiver for medical devices that are being already stored in inventory.
Rules on Standard Date Formatting and UDI Labelling
The FDA explicitly confirms that it is not going to enforce requirements related to the date formatting and UDI labeling applicable to Class I and unclassified medical devices before September 24, 2020, providing that such devices are not implantable, life-supporting or life-sustaining.
The authority also states that medical devices that have been manufactured and labeled before the compliance date could be exempt from the UDI requirement for 3 years.
The document describes the requirements applicable to higher-risk medical devices (Class II and Class III, including life-supporting and life-sustaining ones). First of all, the FDA indicates the following compliance dates based on the class of the device under the risk-based classification:
- for Class III medical devices – September 24, 2016;
- for life-supporting or life-sustaining medical devices – September 24, 2015; and
- for Class II medical devices – September 24, 2018.
However, medical devices of the aforementioned classes could be exempt from the direct marking rule, providing that such devices have been manufactured before the compliance date. The same rule applies when the information to be provided through the UDI could be obtained from other information already marked directly on the device. When considering the eligibility of the particular medical device in question for the application of the aforementioned exemption, the authority will check the availability of such information as catalog number, lot number, and serial number.
Summarizing the information provided hereabove, the present FDA guidance describes the current approach to the labeling and direct marking requirements, the rules related to the unique device identification, and also certain specific exclusions and the way they should be applied.
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