Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law
JULY 7, 2024
FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.
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