Home » FDA Fine-Tuning UDI Final Rule, OTC Exemption May Be Dropped
FDA Fine-Tuning UDI Final Rule, OTC Exemption May Be Dropped
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 would exempt OTC devices to avoid redundancy with UPC codes.
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