FDA Issues Draft Guidance on Coding for IVDs

The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes. Read More

FDA Overhauls Manual on Inter-Center Consultations for Combination Products

The FDA updated its manual on handling inter-center consultation requests between CDRH, CDER and CBER for combination product reviews. Read More

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