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Source & full article: Medical device firms push to comply with new FDA rules.
Medical device firms push to comply with new FDA rules
Gayle Putrich, Plastics News WASHINGTON—The deadline for medical device manufacturers to comply with new U.S. Food and Drug Administration identification rules is coming, but a lot remains up in the air.
FDA’s Unique Device Identification system is a two-pronged approach, requiring both a bar code for machine scanning and text that can be read by the eye on most medical devices. It’s an effort to manage materials better and improve the quality and safety of medical devices coming to and already on the market.
Unfortunately for manufacturers, coming into compliance with the new regulation involves much more than slapping on a new label, and time is of the essence. FDA issued the final UDI rule in late September 2013, and the first compliance deadline, for Class III medical devices and their labels and packaging, is Sept. 24. One year after that, devices described in the FDA Safety and Innovation Act as “implantable, life-saving, and life sustaining,” which are mostly class II devices, have until September 2015. The remaining Class II devices have until 2016 and by 2018, all non-exempt class I devices must also be UDI compliant, according to FDA timelines.