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FDA Backtracks on UDI Compliance Deadlines for Some Class II Devices

September 15, 2016

Manufacturers of certain Class II devices will get two more years to comply with the FDA’s unique device identifier rule, which was scheduled to take effect Sept. 24.

In a Sept. 6 letter to labelers, the agency announced that it would push back UDI compliance dates to Sept. 24, 2018, for repackaged single-use devices, device constituents of certain combination products, and convenience kits consisting of two or more different devices packaged together that are not individually labeled.

The letter explained that the agency had released draft guidance in January on UDI implementation for collections of two or more different devices packaged together. But the agency said needs more time to finalize its interpretation of what constitutes a “convenience kit.” — Tamra Sami

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