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FDA offers guidance on meeting new medical devices tracking rules

By: Gayle S. Putrich

July 1, 2014

WASHINGTON — A final round of in-depth information on the new federal medical device identification database and tracking system is available from the U.S. Food and Drug Administration.

The guidance is meant to provide the technical how-to for the Global Unique Device Identification Database (GUDID), according to FDA, including how to obtain a GUDID account, how to register devices and packaging and how to edit or amend submissions.

In order to finalize the sections with the most questions from device and packaging makers, the GUDID Draft Guidance was completed in phases, the agency said. The first phase was released June 11.

Now, FDA reps said, the new, more-than-40-page-document contains the finalized version of all sections of the draft guidance. The final guidance includes — with minor modifications — the previous sections on how device labelers will interface with the database, establish accounts and begin submissions. The guidance also finalizes the sections on the device identifier record, product labeling submissions, search and retrieval of device information, and submitting and maintaining electronic records.

The finalized guidance also includes an appendix of packaging examples, said an FDA spokeswoman.

The agency has also provided information on how device makers can apply for an exception if the requirements of the new rule are not technically feasible for their device.

The new system is a two-pronged approach, requiring both a bar code for machine scanning and text that can be read by the naked eye on most medical devices. But manufacturers may also apply for an exception if an alternative identification method would provide “a more accurate, precise, or rapid device identification,” the agency says, or if a different labeling system would better ensure the safety or effectiveness of the device.

FDA issued the final 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 compliant, according to FDA timelines.