Friday, May 24, 2013

FDA - Unusual Letter Sent To iPhone-Based Testing Device Co

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product:

"(FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency."  . . .

"Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter."

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