January 16, 2014
Let’s start with what most everyone agrees on: The Unique Device Identification or UDI program is a swell idea.
It gets a little trickier after that.
AdvaMed’s Comments on FDA UDI Implementation
In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, Merck, and more than a dozen others generally voiced support for the UDI concept. However, they found many areas for improvement in the FDA’s September Draft Guidance.
Noting that implementing UDI will be a “costly proposition,” AdvaMed stresses that the implementation plan demands a “living document” approach. This approach will allow the industry and the FDA to update and improve the guidance. Both sides will learn more during setup. AdvaMed follows with 61 specific comments. These comments include suggested changes.
Covidien’s Request for Extended Feedback Period
Coviden, a manufacturer of medical devices and medical supplies, echoes AdvaMed’s comments. Moreover, they toss another 22 into the mix. This includes a request that the guidance remain open for feedback and comment. The deadline is September 24, 2014.
Merck Seeks Clarification on GUDID Scope and Deadlines
Merck, among other commenters, requested clarification and summarization. They want to know the scope of products for which data must be submitted to the Global Unique Identification Database (GUDID). Merck also requested that the FDA include information regarding deadlines for submitting data to GUDID.
Boston Scientific Highlights Inconsistencies in UDI Rule
Boston Scientific
, noting that its medical devices already bear unique identification via HIBCC or GS1 standards. They call the FDA out for what they label “inconsistencies” with the FDA UDI Rule.
To pick one of their examples, and joining several other commenters in making this point, Boston Scientific claims that the “Required?” column in the data elements is unclear. This is because it fails to clarify if it is required to follow the rule based on regulatory requirements or validation requirements. “The meaning of ‘required’ should be clarified so that BOTH regulatory and system validation requirements are clearly identified in this guidance.”
FDA Faces Challenges After Departure of UDI Expert Jay Crowley
FDA’s got its work cut out for it here, particularly with the recent departure of its UDI guru, Jay Crowley, for the greener fields of consultant-dom.
Resources: Jay Crowley’s UDI Implementation Webinar
We can offer some small consolation, though: Crowley leads a webinar on UDI implementation from his new professional perch. Information is here:
Final UDI rule as published in the Federal Register
The entire comment letter line-up is available here
