Home » FDA Extends UDI Compliance Date for Soft Contact Lenses
FDA Extends UDI Compliance Date for Soft Contact Lenses
The FDA is delaying UDI rule requirements for soft contact lenses until one year after it resolves a technical problem — and the agency has granted a third extension for labelers of the lenses.
The FDA granted the extensions because, based on the current industry practice of assigning a different device identifier to each prescription, submission of soft contact lens information would produce a large number of virtually identical records.
Read the FDA’s extension letter here: www.fdanews.com/04-04-17-contactlensletter.pdf.
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