The Food and Drug Administration (FDA or the Agency), the US regulation authority in the sphere of healthcare products, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID) requirements to be applied for certain medical devices. The document is intended to provide additional clarifications on the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. In particular, the document provides revised recommendations on the respective policy. It is important to mention that due to the legal nature of the guidance, provisions contained therein are non-binding and should be construed as such. Moreover, the authority also mentions that an alternative approach could be applied, provided such an approach complies with existing regulatory requirements and has been agreed with the Agency in advance.
Compliance Policy for Class I and Unclassified Devices
First of all, the document describes a revised compliance policy for standard date formatting and UDI labeling requirements for Class I and unclassified devices. In particular, the authority states that it does not intend to enforce standard date formatting and UDI labeling requirements under 21 CFR 801.18, 21 CFR 801.20, and 21 CFR 801.50 for Class I and unclassified devices, other than implantable, life-supporting, and life-sustaining (I/LS/LS) devices, before September 24, 2022. Furthermore, the manufacturers are provided with an additional 3-years grace period for achieving compliance with the requirements regarding placing a UDI. The initial transition period started earlier in September 2018 has expired on September 24, 2021, but to assist medical device manufacturers, and also to ensure uninterrupted availability of medical devices on the market, the authority expands this period for an additional year – now it will expire on September 24, 2022. This approach could be applied to medical devices manufactured before September 24, 2018.
Compliance Policy for GUDID Submission Requirements for Class I Devices
The guidance further describes the approach to be applied to GUDID submission requirements for Class I medical devices depending on the regulatory status of such products.
- Class I medical devices are considered consumer health products. The first category addressed in the guidance is Class I devices considered consumer health products. According to the document, the authority does not intend to enforce the UDI requirements concerning these products – under the general rule, unique device identifiers should be placed on such devices, as well as on their packaging. As explained by the FDA, “consumer health products” stand for 510(k)-exempt Class I devices that are exclusively sold directly to consumers over-the-counter in both brick-and-mortar and online stores. The authority mentions that for these products, a UPC could be used instead of the UDI.
- Class I medical devices are not considered consumer healthcare products. The Agency states in the case of Class I devices that are not considered healthcare products, the approach to be applied should be different, as the risks associated with such devices are higher. Hence, it becomes more important to have all the respective GUDID data in place to ensure the traceability of the product. According to the guidance, these potentially higher-risk devices are typically used in healthcare settings and are often subject to additional regulatory controls. These products are not subject to exclusions described herein, consequently, their manufacturers should ensure compliance with the respective regulatory requirements in terms of UDI starting from September 24, 2022. As further explained by the FDA, this category covers the following types of medical devices:
- Class I Reserved Devices, which stand for any class I devise that is intended for a use which is of substantial importance in preventing impairment of human health… or … that presents a potential unreasonable risk of illness or injury. These products are not exempted from the respective 510(k) requirements.
- Restricted Devices. According to the applicable legislation, FDA may by regulation require that a device be restricted to sale, distribution, or use only upon written or oral authorization by a practitioner licensed by law to administer or use such devices (i.e., prescription use) or such other conditions as may be prescribed in such regulation. It is important to mention that such an approach could be applied not only to general medical devices but to in vitro diagnostic ones as well.
- Implantable Devices. As defined in the respective legislation, an implantable device is the one that is intended to be placed in a surgically or naturally formed cavity of the human body and is regarded as an implantable device … only if it is intended to remain implanted continuously for 30 days or more.
- Life-Supporting or Life-Sustaining Devices. Depending on their intended use, some of the medical devices could be more important in terms of sustaining normal operations of a human body. This applies to the products that are essential to or that yield information that is essential to the restoration or continuation of bodily function important to the continuation of human life.
- Professional Use Devices. Another important category addressed in the guidance covers certain devices distributed to professional healthcare facilities and intended for use by healthcare professionals only. The authority explicitly states that such devices are falling outside the scope of the present policy. According to the guidance, this category includes products that are: (1) reusable or reprocessed, including those that are non-sterile and sterilized on-site before use; or (2) intended for wound care.
Compliance Policy for Unclassified Devices
Apart from the regulatory matters related to Class I medical devices, the guidance also describes the approach to be applied concerning unclassified devices in terms of GUDID submission requirements. According to the guidance, an unclassified device is a pre-amendments device type for which a classification regulation has not been promulgated. Under the general rule, a 510(k) premarket notification is required for such devices to be allowed for marketing and use in the US. Moreover, there are device-specific compliance policies issued by the authority concerning specific unclassified devices. As it is stated by the FDA, it will not enforce GUDID data submission requirements for such products before September 24, 2022, except the cases when such devices are implantable, life-supporting or life-sustaining.
In summary, the present FDA guidance describes the new policy for certain Class I and unclassified medical devices in terms of GUDID submission requirements. The authority indicates the timelines for achieving compliance with the respective requirements and outlines the scope of medical devices eligible for such a transitional period.
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