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USFDA Med Dev Guidances: Intent to Exempt Certain Unclassified Medical Devices & Drug and Device Manufacturer Communications– Questions and Answers
Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not
Sharan Murugan
1 day ago4 min read