OTC Devices May Lose UDI Exemption, FDA Still Fine-Tuning Final Rule

The FDA’s final rule on unique device identification (UDI), due in May or June, will likely not include an industry-backed exemption for over-the-counter medical devices, an FDA official says. The proposed UDI rule exempted OTC devices to avoid redundancy with UPC codes. But after reviewing stakeholder comments, the agency now believes a blanket exemption for OTC devices “would not be helpful,” Jay Crowley, senior advisor for patient safety, said Wednesday.
Devices & Diagnostics Letter