Unique Device Identification – Still Waiting
A recent FDA News article suggests that we will not likely see any new legislation until after the Election.

Drug Pedigree – No Change
California implementation scheduled for January 2009.

Legacy Drugs – New Tactic and Help
The DTA has contacted the Dental Branch of the FDA to get support for our concern over Legacy Drug issues that could make most long-standing dental pharmaceuticals illegal. The costs for filing a "new drug application" are so expensive that most longstanding Legacy Dental Drug manufacturers cannot afford to obtain them. The DTA has made a request to Dr. Susan Runner and Tim Ulatowski at FDA asking whether some Legacy Drugs could be provided a mechanism like that of the 510(k) review to help reduce the cost of keeping Legacy Dental Drugs on the market. More work is required. David Watton from Pascal Dental has been assisting the DTA by working on this issue with the staff and DTA Regulatory Affairs and Standards Committee. Thank you Dave!

ISO 13485 GMDCAS Development at the IAF
The Working Group has grown to 13 full time members and now we have BSI, GMED, UL and TUV all supplying full time representatives. These Conformity Assessment Bodies are helping develop the new IAF Mandatory Document for the Application of ISO 17021 under GMDCAS. This new IAF MD will describe how CAB’s will have to operate under the new GMDCAS accreditation scheme.

We now have representatives from US, Canada, Australia, China, Germany, France, U.K, and Egypt. We are also working directly with the Asian Harmonization Working Party and have two members from the GHTF joining us. I am planning to have to our two primary GMDCAS accreditation documents ready for vote by March 2009.

DTA appointment to the IAF Multilateral Arrangement Management Committee.
The IAF MLA provides the Holy Grail for international trade; "Accepted once accepted everywhere". Our GMDCAS program will have no teeth without having an agreement between nations and economic regions to recognize it. The IAF MLA Management Committee is the highest level group at the IAF, which is charged with developing and overseeing implementation of IAF MLAs. The DTA was nominated by the IAF since it appeared to them that we were the best industry representative among its members.

Registration, Evaluation, Authorization and Restriction of Chemical substances - REACH
Although REACH is a concern for some of our members, the committee has not agreed that it is enough of a concern for the US Dental Industry to tackle as a project for our committee. The reason our committee has not done more is that the information on compliance comes from the EU and largely affects EU based points of operation. http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm. There are plenty of resources available from the REACH website if you are looking for more information or further links that may assist you with compliance. Most of the companies affected by REACH are already well along in their journey toward compliance.

Special Thanks
I want to particularly thank Henry Schein for taking on the Drug Pedigree and UDI issues that have been so much of a concern to our industry. And again thank David Watton and Pascal Dental for the effort they have put into resolving the Legacy Drug Issue. There is, however, much more to be done, and I hope we can all benefit from helping one another, just "as iron sharpens iron, so one man sharpens another".


Keep in touch,

Grant Ramaley
Chairman, Committee on Regulatory Issues
Dental Trade Alliance