FDA Postpones UDI Requirements for Some Implantable Devices
The Food and Drug Administration on Nov. 19 announced it is postponing the date it will require unique device identifiers (UDIs) on certain single-use implantable medical devices that must be sterilized before use (here). Under a final rule issued in…
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September 2013 (see 13092020), implantable devices don’t necessarily have to be directly marked with a UDI, but the UDI must be available at the time they are used, said FDA. This can be difficult for implantable devices that must be sterilized, because they have to be separated from their labeling before the additional step. Although Class I implantable devices had to comply by Sept. 24, 2014, and compliance was required for all other implantable devices by Sept. 24, 2015, FDA is now giving companies until Sept. 24, 2016 to meet UDI labeling requirements for certain devices listed in the agency’s notice. However, the effective date of the requirement to submit information to the Global Unique Device Identification Database (GUDID) is unchanged, said FDA.