FDA Releases Proposed Rule on Medical Device Tracking System

TOPIC ALERT:

On Tuesday, FDA announced that it has released a proposed rule to create a unique device identification system to track medical devices, Health Data Management reports (Goedert, Health Data Management, 7/3).

Background

There currently is no uniform labeling system for medical devices, making it difficult to track down problematic equipment used by hospitals and patients. A UDI system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety (iHealthBeat, 6/5).

Lawmakers recently took steps to expedite the creation a UDI system by adding language to a FDA user fee bill (S 3187) that would establish a deadline for FDA to create a UDI system (iHealthBeat, 6/20). Last week, the Senate passed the House-approved bill and sent it to President Obama, who is expected to sign the measure into law (Perrone, AP/U-T San Diego, 6/26).

Details of FDA's Proposed Rule

FDA in a statement said it released the proposed rule in response to the new user fee legislation (FDA release, 7/3).

The proposed rule would require medical device manufacturers to place UDI codes on their products to identify each device's:

  • Make;
  • Manufacturer; and
  • Lot number.

Such codes would be stored in a public database so regulators, physicians and companies could monitor safety issues related to the devices (AP/Sacramento Bee, 7/3).

Next Steps

The proposed rule is scheduled to be published in the Federal Register within a week (Health Data Management, 7/3).

After its publication in the Federal Register, FDA will accept public comments on the proposed rule for 120 days. The agency plans to consider the public comments before finalizing the rule (Yukhananov, Reuters, 7/3).


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