Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices which extends the GUDID database entry deadline for certain Class I and Unclassified over-the-counter devices.
The subject of the document is precisely Consumer Health Products, i.e., devices sold directly over-the-counter (OTC) to the consumer or in online stores.
The following devices are not considered Consumer Health Products:
- Class I Reserved Devices, i.e., devices that require a 510(k) procedure;
- Restricted Devices, devices for professional use or sold by prescription;
- Implantable Devices, placed and implanted in the human body for 30 days or longer;
- Life-supporting or life-sustaining devices;
- Devices distributed to health care facilities, intended for use only by professionals, if: a) Subject to reuse or reprocess; or b) Intended for wound care.
However, not all Consumer Health Products are eligible for the extension but only those belonging to Class I or Unclassified and subject to mandatory UDI code on the label and/or packaging.
The deadline for the registration in the GUDID database of the aforementioned devices, former 21 CFR 830.300, is December 8, 2022, thus extending by 75 days the original deadline of September 24, which, however, remains valid for the affixation of the UDI code in the label and/or packaging.
Do you need more support?
>>> Thema’s experts can provide the necessary strategic and operational assistance for the implementation of the UDI system, along with registration in the GUDID database, as requirements for device commercialization in the US market.
>>> Thema can support you in fulfilling all pre- and post-market requirements required by 21 CFR and U.S. federal regulation, enabling smooth and efficient device entry and distribution.
>>> Appoint Thema as your U.S.Agent and U.S.Initial Importer, key roles required by regulation in order to market your devices in full autonomy.
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