FDA outline new medical devices guidelines

Medical device manufacturers have been given some idea of the US Food and Drug Administration's (FDA's) new identification rules.

The FDA's Unique Device Identification system will be a two-pronged approach that needs a manufacturer to provide both a barcode for machine scanning and text.

It is hoped this will improve the quality and safety of medical devices coming to the market.

The deadline for the new labels and packaging of Class III medical devices is September 24, while devices described in the FDA Safety and Innovation Act as "implantable, life-saving, and life sustaining," need to be relabelled before 2015. 

Manufacturers of the remaining Class II devices have until 2016 to become compliant.

"A labeller may submit a request for a one-year extension of the compliance dates for a class III medical device or a device licensed under the Public Health Service Act," explained FDA spokesperson Jennifer Rodriguez.