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See today's BioWorld MedTech
Home » FDA eyes greater degree of specificity regarding materials in device labeling
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FDA eyes greater degree of specificity regarding materials in device labeling

May 21, 2021
By Mark McCarty
The FDA’s November 2019 two-day hearing regarding the use of metals in medical devices generated at least one actionable recommendation, namely that manufacturers disclose all materials used in devices in product labels. The agency has reacted to that recommendation in the form of a discussion paper that proposes to require that product labels provide a deep level of detail regarding the materials found in the device, a notion that received the backing of industry during the November 2019 hearing.
BioWorld MedTech Regulatory U.S. FDA

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