UDI

[JayH]

Someone recently posted the following on the dental-lab mailing list. I didn't see it generate a lot of discussion but have been looking into it as of late.

In all of the regulatory and government language I have come across the dental lab industry seems to be more of an afterthought than a primary concern to the subject. Vague comments have been made to the (im)practicality of bar-coding crowns, etc but I have found nothing of significance to make me think we need to start making any changes, yet.... The bulk of the discussion centers around hospitals and their suppliers. Even the ERG final report makes only passing references to our industry.

Any thoughts or comments?

Unique Device Identification (UDI) is Coming
FDA first steps to adopt a UDI system
[FONT=&quot]
[/FONT]
It's anticipated that in the first quarter of 2012 the Food and Drug Administration (FDA) will announce the first official steps to adopt a Unique Device Identification (UDI) system for the medical device industry. UDI will mandate that manufacturers and distributors assign bar codes to their products and equipment that identify the name of the manufacturer, manufacturer’s contact information, date of origin, lot number, date of shipment, the product’s class (I, II or III device, risk classification),any expiration dates and other pertinent information.

Due to DTA efforts, most dental devices will only be required to have their UDI numbers printed on the box or packaging and not on the actual device. The exception is some Class III devices such as defibrillators.

Most dental devices will be included in the final group of devices requiring UDI adoption in approximately three years from the official date of adoption. Class III devices, representing devices with the highest patient risk, will be required to adopt UDI procedures, most likely beginning in calendar year 2013.

All manufacturers will be required to pay a fee to have their products assigned UDI numbers. Those fees have not yet been determined. Manufacturers will also bear the cost of having to redesign their packaging to accommodate two UDI barcodes. Once FDA releases its final recommendations, DTA will provide its members with more specific details.

To learn more about this new system for identifying and monitoring devices manufactured and sold in the US, go to Workshops & Conferences (Medical Devices)

 

[Tom Moore]

Our products have no history of patient harm. We are an afterthought.

 

[Mark Jackson]

Compliance will be easy. Implant Surgical Guides are a ticking time bomb....mark my words.

 

[DMC]

We now have Part Labeling in SUM3D CAM!

CIMSystem Srl


Bob, It also sprues together Two adjacent teeth as well, despite you thinking otherwise. I don't know why you say that? I posted a screen shot, but you still went on about it lacking that feature.

It had it all along. ??

 

[AJEL]

This in part is being discussed by both the IRS & FDA. If U R a NADL check with them on currently what is going on, I would love to find more on this but the $370. is still holding me back from joining. (I'm cheap & broke)
Comments and Public Hearing
Before these proposed regulations are adopted as final regulations,
consideration will be given to any written (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. The IRS and the Treasury Department request comments on the clarity of the proposed regulations and how they may be made easier to understand. All comments will be available for public inspection and copying.
A public hearing has been scheduled for May 16, 2012, at 10 a.m., in the IRS
Auditorium, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Due to building security procedures, visitors must enter at the Constitution Avenue
entrance. In addition, all visitors must present photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the immediate entrance area more than 30 minutes before the hearing starts.
Alternatively, taxpayers may submit comments electronically to [email protected]. Please include “Notice 2010-89” in the subject line of any electronic communications.

 

[JayH]

A public hearing has been scheduled for May 16, 2012, at 10 a.m., in the IRS Auditorium, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Due to building security procedures, visitors must enter at the Constitution Avenue entrance.

Got a link to this public notice?

 

[vurban210]

AJEL, is that from the recent guidance released by the IRS regarding the Medical Device Excise Tax?

http://www.irs.gov/pub/newsroom/reg-113770-10.pdf

 

[JayH]

Which is not UDI.

AJEL, is that from the recent guidance released by the IRS regarding the Medical Device Excise Tax?

http://www.irs.gov/pub/newsroom/reg-113770-10.pdf

 

[vurban210]

Which is not UDI.

Jay, I had read the notice on the excise tax over the weekend and remembered the dates looked similar.

That was why I asked AJEL if he was perhaps referring to that document.

I did however answer your question, as I sent you a link to the public notice that was referred to in the previous post. Although you are correct it is not in reference to UDI.

I guess I should have made all that clear in my original post.

 

[AJEL]

Jay I think I misunderstood, that is reference to the new tax. I have read they were to discus the classification of FDA & IRS for tax purposes. Fortunately we don't have to barcode our artwork yet.

 

[JayH]

Thanks guys. Just wanted to make sure I wasn't missing part of the UDI equation. And it will help clarify the distinction when anyone searches for 'UDI' by topic and run across the link to the IRS excise tax.