FDA Delays GUDID Deadline Due To Security Flaw
Due to an unspecified security flaw in the Global Unique Device Identification Database (GUDID), the FDA has extended its original Sept. 24 compliance deadline by one month until the issue can be properly addressed. Manufacturers of certain Class III medical devices will have until Oct. 24 to submit the required labeling information and data.
In order to create centralized location to house the most up-to-date information about medical devices on the market, the FDA developed the database, where device manufacturers can upload labeling information, warnings, and any updates that may crop up in a device’s postmarket life cycle. This would allow patients and doctors access to the latest information as soon as it was available.
“The unique device identification system will help reduce medical errors and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions,” said the FDA in 2012.
Though the database is maintained by the FDA’s Center for Devices and Radiological Health (CDRH), each manufacturer is responsible for uploading and maintaining data for every device registered with the FDA and assigned a device identifier (DI).
According to the Regulatory Affairs Professional Society (RAPS), the compliance dates were staggered depending on the device’s classification. Since the database’s launch in 2013, the FDA has issueda few extensions. For example, many high-risk devices (Class III) were to be correctly labeled and their data uploaded by last September, but the FDA extended the deadlines for certain devices, including intraocular lenses (1 year) and orthopedic implants (2 years).
Last week, the FDA issued a statement saying that the deadline had been pushed back yet again because it discovered a security issue with the database on Aug. 7. Because the system will be offline until it is patched, the FDA has elected to extend the deadline for all devices that have a Sept. 24, 2015 compliance date by one month.
“Due to the temporary unavailability of the GUDID system, we intend to exercise enforcement discretion to extend the Sept. 24, 2015, GUDID submission compliance date for the implantable, life-supporting and life-sustaining medical devices to Oct. 24, 2015,” said the FDA in the statement.
Dan O’Leary, president of Ombu Enterprises, detailed to Med Device Online in December step-by-step instructions for manufacturers to submit their data in compliance with the new regulations.