FDA Extends Compliance Dates

The FDA has extended the compliance date for UDI label AND GUDID submission requirements to September 24, 2018, for certain class II devices.

In addition, the FDA is stating that for device constituents of certain combination products the compliance date for UDI label and GUDID submission requirements is September 24, 2018.

1.Convenience Kits

Collections of two or more different devices packaged together in which the devices in the package are not individually labelled.

Why?

On January 4, 2016, the FDA issued a draft guidance document on “Convenience Kits” in  which the agency proposed an interpretation of the term “Convenience Kit” for purposes of applying the exception under 21 CFR 801.30(a)(11).  The FDA needs more time to finalize this draft guidance document and their interpretation of what constitutes a convenience kit.

Therefore the FDA is extending the compliance date for UDI label and GUDID submission requirements for collections of two or more different class II (or class II and class I) devices packaged together in which each device in the package is not individually labelled.

Please note that this extension does not apply to collections of devices that include one or more devices that are implantable, life-sustaining or life-supporting.

For those that have already implemented the UDI label requirements for these devices this extension would apply only to the GUDID submission requirement.

2. Repackaged single-use devices

21 CFR 801.30(a)(3) provides that individual single-use devices, other than implants, all of a single version or model, are not required to bear a UDI provided they are distributed together in a single device package, intended to be stored in that device package until removed for use, and not intended for individual commercial distribution.

The UDI label and GUDID submission requirements’ compliance dates for repackagers of class II single-use devices that are not individually labelled with a UDI is extended to September 24, 2018.

This extension does not apply to implantable, life-supporting or life sustaining devices.

For device constituents, other than devices that are implantable, life-sustaining or life-supporting, of 21 CFR 3.2(e)(2)) (commonly referred to as “co-packaged”) and 21 CFR 3.2(e)(3) (commonly referred to as “cross-labeled”) combination products assigned to Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for premarket review and regulation, the compliance date for UDI label and GUDID submission requirements is September 24, 2018.

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