New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations
FDA Law Blog
OCTOBER 17, 2023
This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.
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