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Steven Niedelman

Publications

Unique Device Identifier (UDI) Fundamentals


Question: What can life sciences companies expect from the UDI program? Answer: Although many in industry may be quick to view the UDI as only a “labeling rule,” the impact of...

Product Labeling Requirements


Question:How do product labeling requirements differ between medical devices and pharmaceuticals? Answer: The FDA has stringent regulations regarding the labeling of medical...