FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals
The Premier Consulting Blog
NOVEMBER 20, 2023
Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Expanded Definition: FDA aims to reshape the boundaries of IVDs within 21 CFR Part 809.3.
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