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Written by DTA Regulatory Consultant, Blix Winston.

The FDA has issued the final version of the reprocessing guidance for 510(k) submissions and provided a help helpful guidance webinar that you can watch at www.fda.gov/training/CDRHlearn

The revised guidance contains must-have information if your 510(k) submission includes either sterile devices or devices that you intend the end user to clean and reprocess. Much of the discussion about this during a recent meeting between FDA and DTA centered on how FDA expects applicants to conduct validation of cleaning and sterilization processes. For example, FDA expects that two quantitative tests will be conducted for cleaning. Applicants should validate these tests to measure residual soil on your device, including negative and positive controls. Microbial log reductions should not be used to validate cleaning soiled devices. Soils appropriate to the environment in which the device is used should be considered.

The guidance is not retroactive but applies to submission received by FDA after Mar. 24, 2015.  Validation of cleaning and sterilization process should be treated independently in the submission.

One question at the meeting concerned cleaning agents. If your application recommends five different cleaning agents and three sterilization methods can be used, you should test all 15 combinations to validate that they work.

February is Children’s Dental Health Month!  To kick off this month, the Ad Council has released an update on the Kids' Healthy Mouths campaign that has garnered more than $78 million in donated media since its launch in 2012.  A second phase of creative materials has just been released to media outlets nationwide.  New Toothsavers mobile video game characters (Rabbit, Pinnochio and Alice In Wonderland) will be available and there is continued support from Scholastics with materials for caregivers and teachers.  “Created pro bono by Grey New York, the Kids’ Healthy Mouths PSAs stress that while most parenting is difficult to do in two minutes, such as learning how to cook or ride a bike, making sure kids brush for two minutes, twice a day is something a little simpler. The Zooppa video contest winners capture the spirit of the original PSAs and feature a lighthearted look at parenting today. The videos will be highlighted on the Kids' Healthy Mouths social pages throughout the month of February.”  PR Newswire, New York, February 10, 2015

 Campaign Website:  www.2min2x.org 

Ad Council Website:  http://adcouncil.org/Our-Campaigns/Health/Children-s-Oral-Health

Partnership Website:  www.healthymouthshealthylives.org 

The DTA Foundation raised $117,172 through the Silent Auction held during the 2014 DTA Annual Meeting.   Funds raised from the auction support the Foundation’s Grants and Scholarship programs.  As an example of what your donations can do, $100,000 allows the Foundation to fund 4 grants or up to 20 scholarships!  This is the first year that all proceeds from the auction went directly to the Foundation.  It was also the first year to utilize mobile bidding. DTA members quickly mastered this new format and participated in a fun evening of raising awareness for increased access to oral health in America.

A wide range of prices for items at this year’s auction enabled even more people to participate.  In addition to traditional ad spaces and sports memorabilia, many fun and exciting new items were available. A beautiful pair of Tiffany pearl drop earrings generated quite a buzz.  Other unique items included a Pinehurst Golf experience, a Taste of Tennessee Bourbon Tour, and a Kayak and GoPro camera package.

Thank you to all who generously donated items to the auction and to all who participated in the bidding.  We look forward to an even bigger auction next year to increase the direct impact you have on oral health in America!

Taking Full Advantage of Your Chicago Midwinter Meeting

The Chicago Dental Society Midwinter Meeting is a busy week for the dental industry. It is one of the first major dental meetings of the year and a growing international dental event. Take full advantage of your time in Chicago by attending a number of DTA sponsored activities that are designed to enhance your Chicago Midwinter opportunities.

Arrive in Chicago on Wednesday, February 25th for the Future Trends Forum followed immediately by the DTA Preview Show at the Hyatt Regency McCormick Place adjacent to the McCormick Center and Chicago Dental Society Midwinter Exhibition. This year, the Future Trends  Forum takes on a provocative subject –gray market sales. Find out how companies are dealing with the challenges of unintended dental products sold or re–imported back into the US market. Learn from leading professionals how they address this issue. Understand how the implementation of Unique Device Identification (UDI) impacts the sale of gray market dental products.

Immediately following the Future Trends Forum is the Preview Show, the best business-to-business event for dental companies in the US. Manufacturers will be highlighting their latest products and small equipment. US and foreign distributors will be attending the Preview Show looking for new companies to partner with and for new technologies to bring to the dental office. This year’s Preview Show offers a number of new innovations including private meeting spaces, sign–up sheets to request a private meeting with a manufacturer (ahead of time or on–site) and VIP passes for attendees who want to beat the competition to meet with table top exhibitors before the crowds arrive.

The following day, the Emerging Leaders are hosting a Wine and Food Pairing – so executives can learn more about serving the proper wines with great food when entertaining clients. A leading sommelier from Midmark Corporation will lead the group through a half dozen different wine tastings and food pairings. This event will be marked by plenty of great food, top wines and a lot of high level networking. The event takes place Thursday evening, Feb 26th at the Omni Hotel, 676 N. Michigan Avenue from 6:30 to 9 pm. Highly recommended for all your sales managers and executive team.

As a Dental Trade Alliance member, your company dues go a long ways towards strengthening the dental manufacturing and distribution industry from legislative advocacy, to professional education, to networking, to promoting improved oral health care for Americans.

DTA serves as a strong voice for the industry with its advocacy efforts in Washington. From the DTA’s annual Washington Conference to meet with congressional representatives, to its ongoing advocacy and analysis, DTA is there addressing the issues impacting your business and the dental industry, in general.

Your dues also go to programs that support and serve you, the member company, and your staff:

Member education strengthens organizations and strengthens the industry as a whole with courses that include:

Mini-Dental and Mini-Dental Hygiene School – Take a walk in your dental customers’ shoes with a two-day, hands-on dental school experience in Denver and Washington D.C.

Introduction to Dentistry – The complete online dental education without leaving your desk. It is ideal for new employees who want to hit the ground running.

Webinars – Gain an edge with a variety of educational programs covering topics from business best practices to professional development.

Information on Regulatory Affairs and Standards – Meet with FDA officials and regulatory experts on key issues that affect your business.

Consultation Services – Call on us to help with your industry questions and concerns.

Community outreach  is yet another critical use of  your annual dues. DTA participates in the National Roundtable for Dental Collaboration and serves as the driving leadership force in the Ad Council campaign for the Partnership for Healthy Mouths, Healthy LivesDTA understands that fostering oral health literacy is not only the right thing to do but is also a positive way to grow our future business.

Stay informed.  Connect with us on Twitter, Facebook and LinkedIn

Excerpted from the November 2014 issue of Mentor

We’ve now been through our first cycle of the Centers for Medicare and Medicaid Services’ (CMS) Open Payments reporting program — better known as the Physician Payments Sunshine Act — and there were a few snafus. This is the federal program that’s designed to provide transparency in financial relationships between medical and dental manufacturers and physicians and dentists. These are called “transfers of value,” and might include speaking fees, gifts, meals, travel or funding for research.

First, the CMS took down its online payment verification system after discovering that a “small number” of doctors had been confused with others with the same name. Then, verification and resolution due dates had to be extended. The CMS also had to return a third of the records it received because of reporting errors. As a result, a number of disclosed payments to doctors from 2013/2014 will not be reported on the database until sometime next year.

Read the full article at MentorIsSalesPower.com.

Despite that tooth decay is the single most common chronic childhood disease in the U.S., 75 percent of parents report that their kids sometimes or frequently forget to brush their teeth, according to a national survey released by the Ad Council.

It’s estimated that children miss more than 51 million school hours each year due to dental-related illness, yet the survey shows parents perceive their children’s dental health as a low priority compared to other issues such as school safety, nutrition and the upcoming cold and flu season.

Recently, the Dental Trade Alliance Foundation awarded $193,924 in grants to provide funding for innovative oral health programs aimed at encouraging changes in consumer behavior, improving access and enhancing the efficiency of the oral health care system. These grants were made possible by Dental Trade Alliance members’ generous donations to the foundation.

Become your dentists’ trusted resource and you’ll help them grow their dental practice and provide better care for their patients. While these challenging times are producing angst among dentists, they can present an opportunity for you. You can become your dentists’ trusted resource and help them see beyond their practice walls to the larger trends and opportunities in dentistry today.  

Read more at First Impressions Magazine.

Excerpted from the September 2014 issue of Mentor

A good thing turns bad when there’s too much of it. Take the example of “too much information.” Every parent wants to know what their children are up to, but they’re probably not interested to learn about the treasure that little Johnny or Susie found sifting through the kitty litter. So it goes with dental trade shows. These events can be beneficial in boosting field sales and generating leads, but the number of shows — and, in some cases, shrinking attendance — are cause for concern among manufacturers and distributors. When it comes to meetings, the challenge for dental companies is knowing which venues are producing — and which they’re better off turning their noses up at.

In today’s super-competitive climate, it’s all about discovering which exhibitions offer a solid return on investment, and then finding creative ways to leverage those venues for maximum brand-building and sales impact. And while there’s no bulletproof cost/benefit formula that works for every firm, there are strategies that can help dental companies determine the “right shows” to which they should commit their resources.

Read the full article at MentorIsSalesPower.com.

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