Thursday, August 21, 2014

FDA Gives Contact Lens Manufacturers a Year to Comply with UDI Rule

“Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry,” reports One group: Contact Lens manufacturers. “In an announcement this week, FDA indicated that at least one group of devices had been granted an extension. Class III contact lens and intraocular lens labelers, FDA said, would have until September 2015 to label their products in accordance with the UDI rule's direct marking requirements. The reason for the delay, FDA explained, was because of the likelihood of an ‘extremely large number of data submissions to the Global Unique Device Identification Database (GUDID)’—a number so large that FDA implied it might be a burden upon both the industry and its database.”  Read more.

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