|Under the FDA's UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA|
It turns out the FDA's new rule requiring unique device IDs (UDIs) for high-risk medical devices was only half the battle.
Industry groups such as AdvaMed and major med tech companies including Abbott ($ABT), GE Healthcare ($GE), Covidien ($COV), Johnson & Johnson ($JNJ) and Cook Group are among those that recently submitted 21 sets of comments on the FDA's draft guidance that would govern the data submission process, Bloomberg BNA reported.
As it stands, device companies must comply with the rule in stages over the next few years, which calls for the collection of device data via a unique number and barcode that will ultimately be registered with the FDA and loaded into a publicly searchable database. To get there, regulators must hash out how that data will be submitted, and the back-and-forth between industry and the FDA over draft guidance designed to govern that process continues in full force.
Regulators' goal here is to create a process that allows for a clear way to identify and track medical devices to collect more reliable data about how they're used. That data trove should help promote safe device use by creating a way to quickly access information about problems. And such a system could also lead to information sharing that leads to innovative and more cost-effective device development, the FDA has said.
But the device industry is hopeful that the system ultimately will be easy to use and won't be a bureaucratic and logistical drag on any of the aforementioned goals (HealthCare.gov, anyone?). J&J, for example, wants the system to have a way to update internationally recognized terms for medical devices once they become obsolete. AdvaMed urged regulators to keep the UDI process and database fluid, allowing it to be updated and improved along the way. The Cook Group implored the FDA to create a system that lets companies upload information that they can safe in draft form without harming data that's already published, according to the story.
This could end up being a fairly long process, considering a lot of the issues involve mechanics and back-end systemic concerns. Precedent also comes into play, considering the FDA imposed its final rule on UDIs in September after months of debate and delay. It's not surprising that guidance concerning implementation might also take extra time.
High-risk Class III devices such as pacemakers and vascular implants must comply with the rule within a year. The more moderate-risk Class II devices must work with a three-year timeline in order to comply. Most Class I devices are exempt, but those that aren't have 5 years to meet the requirements, the FDA said.
- read the Bloomberg BNA story