The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and life-supporting/life-sustaining devices.
The US Food and Drug Administration (FDA) issued a new enforcement policy on July 1 that
- extends the enforcement discretion for compliance with Unique Device Identifier (UDI) requirements and Direct Marking for Class I and Unclassified devices (other than implantable, life-supporting, or life-sustaining devices[1]); and
- suspends enforcement of Direct Marking requirements for
- Class I and Unclassified devices that are not LS/LS devices, are nonsterile, are manufactured and labeled prior to September 24, 2022, and remain in inventory; and
- finished Class III, Life-Supporting/Life-Sustaining (LS/LS), and Class II devices that are nonsterile, are manufactured and labeled prior to their compliance date, and remain in inventory.
FDA explains that part of the reason for granting the enforcement discretion is the COVID-19 pandemic, citing the difficulty of trying to implement the UDI requirements during the pandemic if a labeler has not already done so (enforcement was slated to begin in September 2020).
By granting the discretion, FDA hopes that labelers can remain focused on current public health needs related to COVID-19.
CLASS I AND UNCLASSIFIED DEVICES
FDA will enforce the following requirements on Class I and Unclassified devices on September 24, 2022:
- Standard date formatting per 21 CFR § 801.18
- UDI labeling per 21 CFR § 801.20 and 21 CFR § 801.50
- Global Unique Device Identification Database (GUDID) data submission per 21 CFR § 830.300
- Direct Marking requirements per 21 CFR § 801.45
The enforcement discretion also applies to Class I and Unclassified devices that were manufactured and labeled prior to September 24, 2018. FDA will enforce the requirements listed in the bullet points above on all Class I and Unclassified devices, regardless of their manufacturing or labeling date, on September 24, 2022.
Finally, the policy suspends enforcement of the Direct Marking requirements for finished Class I and Unclassified devices so long as
- the devices are manufactured and labeled prior to September 24, 2022;
- the devices remain in inventory as of September 24, 2022; and
- the devices’ UDIs can be derived from other information directly marked on the devices.
The enforcement discretion is also afforded to Class I and Unclassified device constituents of a co-packaged combination product or kit that are not LS/LS and are nonsterile.
CLASS III, LS/LS, AND CLASS II NON-STERILE DEVICES
The policy suspends enforcement of the Direct Marking requirements for finished Class III, LS/LS, and Class II devices as long as
- the devices are nonsterile;
- the devices were manufactured and labeled prior to their established Direct Mark compliance date (see below);
- the devices currently remain in inventory; and
- the devices’ UDI can be derived from other information directly marked on the devices.
The established Direct Mark compliance dates were as follows:
- Class III devices: September 24, 2016
- LS/LS devices: September 24, 2015
- Class II devices: September 24, 2018
Prior to the policy, FDA intended to enforce the Direct Marking requirements for these finished devices three years after the compliance date.
Law clerk Angela M. Silva provided helpful contributions to this article.
[1] The policy does not apply to Class I and Unclassified devices that are implantable, life-supporting, or life-sustaining (I/LS/LS). I/LS/LS devices of all classes were required to comply with labeling, direct mark, and GUDID submission requirements under 21 CFR §§ 801.20, 801.45, 801.50, and 830.300, as well as the standard date format requirement under 21 CFR § 801.18 by September 24, 2015, unless an exception or alternative applied.
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