FDAnews
www.fdanews.com/articles/11480-fda-extends-udi-compliance-date-for-soft-contact-lenses

FDA Extends UDI Compliance Date for Soft Contact Lenses

April 7, 2017

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.