Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 19 August 2015 | By Michael Mezher
After discovering a security flaw in the Global Unique Device Identification Database (GUDID), the US Food and Drug Administration (FDA) is giving device makers an additional month to comply with new labeling and data submission requirements.
In 2013, a new set of regulations required companies to comply with new labeling and data submission requirements, with staggered compliance dates based on device classification.
Specifically, companies distributing devices within the US would need to include a UDI on each device, combining static and dynamic identifiers. According to FDA, these identifiers "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 that focus sharply on the specific devices that are of concern."
Many high-risk, or class III, devices were required to comply with UDI and GUDID requirements by 24 September 2014. However, certain products, including some orthopedic implants and intraocular lenses, were given additional time to comply.
FDA gave non-class III devices that are "implantable, life sustaining and life supporting," until 24 September 2015 to comply with UDI and GUDID requirements.
However, after discovering a security flaw in the GUDID on 7 August 2015, FDA has said it has "decided to take the system offline until a patch is implemented" and will exercise its enforcement discretion to extend the compliance date to 24 October 2015, giving affected labelers an additional month to comply.
FDA
Tags: GUDID, Global Unique Device Identification Database, Unique Device Identification