I should have caught this in July when FDA NEWS posted this update from Jay Crowley, who is the Food and Drug Administration’s senior adviser for patient safety:

When the FDA begins to implement a global unique device identifier (UDI) system, Class III devicemakers will be the guinea pigs as regulators “work out the kinks.”

Class III devices, according to this Wikipedia source, are devices that require premarket approval. Examples include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).

The logic seems to be that the smaller Class of products will be an easier place to start and to gain experience before applying the new UDI rules across the board: “Our goal is to start small and ramp up over time as well as learn what the issues are,” Crowley said. “We’ll start with Class III, learn from that, then implement rules on Class II and eventually Class I devices.”

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