Back to top

News

By September, medical device manufacturers and distributors—including dental manufacturers and distributors—are required to implement Unique Device Identification (UDI) for all class II devices that are sold in the U.S. There are very few exemptions allowed.

The UDI is a new track and trace system for devices mandated by Congress with the final rule announced by the FDA. There are a number of moving parts to this UDI tracking system. This includes a unique bar code accompanied by a human readable element (numerals or numerals and letters) for all devices. The UDI itself may be located on the packaging or on the device itself. There are two parts to each UDI. They include: the device identifier, which is a fixed element consisting of the manufacturer (or labeler) and the specifics of that device. The second part is the product identifier, which describes the lot or batch number, serial number, expiration date, etc.

Device manufacturers and distributors must select from one of several issuing agencies that provide UDI numbers and bar codes. These include HIBCC, GS1 and ICCBBA. There are fees to get UDI licenses from the issuing agencies. There are discounts for multiple device UDI licenses. In addition, companies must upload their devices with the proper UDI to the FDA managed Global Unique Device Identification Database (GUDID). Device companies can upload the UDIs themselves or pay a vendor to upload these UDIs for them.

It may be useful to discuss your UDI project with your preferred distributor or manufacturing partners. In some cases, a device package may have to be redesigned to accommodate the UDI in both the bar code and human readable formats. FDA is allowing a grace period of 180 days for devices that are already manufactured and have been shipped to other warehouse facilities. Following the grace period, there could be fines assessed for non–compliance. In a worst case scenario, companies could be prevented from selling their non–compliant devices in the U.S.

For questions regarding UDI, contact the FDA’s UDI Help Desk. Do not telephone or e-mail the FDA separately. All inquiries flow through the UDI help desk. Companies may need to discuss the project with an outside consultant to assist with UDI compliance.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

As we watch what seems to be one of the most chaotic political seasons in memory, it may seem that the future is not clear and it may create concern for some.  While I must admit that my political crystal ball is quite foggy on the outcome of this year’s November elections, I can state with confidence that the dental industry will be ready to work in a bipartisan way with whomever is elected.

Last year at the end of 2015, two significant policy changes were enacted that provided dental manufacturers with good news that helps DTA members make plans for their business growth.  The first of these two changes involved a two-year moratorium on enforcement of a 2.3% excise tax on medical and dental devices, which was first authorized as part of the Affordable Care Act (ACA) in 2010.  The second addressed long-standing concerns with Section 179 expensing provisions of the tax code. Congress addressed this issue in a permanent manner after years of temporary fixes, which always seemed to come late in the calendar year. 

What is significant about these positive steps forward in 2015 is that they occurred in a divided government. As Republicans control the House and Senate, Democrats continue to control the White House. Only by working to find common ground between the political parties were these two positive advancements possible.

It is clear that the Senate, which today is controlled by Republicans, is increasingly likely to be controlled by Democrats in the next Congress. This is in part due to the number of Republican senators who are up for election in comparison to Democrats. Of the 34 Senate seats up in 2016, Republicans hold 24. Democrats will need to gain 4 or 5 seats to take control.  The House is controlled by Republicans currently and even with possible significant gains by Democrats this November it will likely remain in the control of Republicans. Of interest though is that no Republican House members have lost their primary election so far this year that may translate into fewer losses than would have been previously predicted.

The race for the White House is less clear, to put it mildly. While the pundits predict that a Democrat (who is yet to be named) will have an electoral advantage given the lack of unity on a Republican candidate, fortunes can and may change. One thing has been clear during the presidential primary season: Pundits have been dead wrong on just about every turn.

Regardless the outcome of the elections, the DTA will be working with all elected officials to seek repeal of the medical/dental device excise tax as the two-year moratorium comes up for further debate. The DTA will also be making the business and public health case for continued expansion of access to dental benefits that can reduce the costs of chronic disease. It will also be seeking common sense solutions to the ongoing impacts of the Sunshine Act, which requires reporting of financial interactions with dentists and other health care professionals. 

I think Yogi Berra said it best when he stated, “The future ain’t what it used to be.”

 

This article was prepared by Patrick Cooney in his personal capacity. The opinions expressed in this article are the author's own and do not reflect the view of the Dental Trade Alliance.

wcThanks in no small part to member visits during the DTA Washington Conference, we’ve enlightened Congress about the onerous nature of certain legislation. One such example is the 2.3 percent Medical Device Excise Tax, and they have responded with action that benefits our industry. However, our work is not done. We need your help at this year’s Washington Conference to continue pressing for our industry’s best interests.

The Medical Device Excise Tax, which was supposed to take effect this year, has been delayed for two years. This was a great success for our efforts, but now we must set our goals to ending the excise tax completely. Together, we can do this. While many organizations lobbied against the medical device tax, DTA was front and center with a small group of members of Congress that, in the end, were almost solely responsible for its modification.

The DTA Washington Conference has become one of the most important ways you, as a member, can become involved in federal legislation and educate congressional leaders about oral health care and our industry. During the conference, members attend a legislative briefing and meet with their elected officials and their staffs to discuss the issues. You are the most valuable resource the industry has when it comes to building relationships with our elected officials and initiating change.

We look forward to seeing you April 26-27 in Washington. Get more details about the Washington Conference and register here.

Years of DTA members’ efforts to educate Congress have come to fruition with a significant victory for the dental industry in the passage of the Protecting Americans from Tax Hikes (PATH) Act. This act suspends the Medical Device Excise Tax, makes permanent several lapsed business incentives and renews a handful of provisions that are pertinent to the dental industry. 

“While many organizations lobbied against the medical device tax, DTA was front and center with a small group of members of Congress that, in the end, were almost solely responsible for its modification,” said DTA President and CEO Gary Price. “All of us owe a great debt to the many DTA volunteers who came to Washington multiple times to lobby on this issue. These members will tell you how important it is to be involved and be persistent in your message. If you haven’t joined us for our Washington day, you should make plans to attend in 2016. Now you can see that it actually works.”

The PATH Act received bipartisan support in both the House and the Senate. While one can argue the benefits and the costs of such sweeping legislation, it is generally accepted that this bill, on the whole, will have a positive net effect for the dental industry and for dental manufacturers. 

“The DTA and its members have supported a repeal of the Medical Device Excise Tax since its inclusion in the PPACA,” said DTA Chairman Eric Shirley. “DTA and its members have worked tirelessly to explain the consequences of the tax during the Washington Conference, our legislative event on Capitol Hill, and in many discussions with members of Congress. Thank you to all of the many members of the DTA and for the DTA staff who drove these efforts.”

The PATH Act has many positives for the dental industry. Here are some of the highlights of the act, pertinent to the dental industry. We encourage you to seek additional counsel as to how these provisions will impact your company.

Medical Device Excise Tax Suspended

The Medical Device Excise Tax is suspended for sales in 2016 and 2017.

Research and Experimentation Credit Made Permanent

For taxable years beginning after 2015, the credit is modified to allow an eligible small business (as defined in section 38(c)(5)(C)) to claim the credit against both its regular tax and alternative minimum tax (AMT) liabilities. Beginning in 2016, certain small businesses also may claim the credit against the employer portion of their payroll tax liability, rather than against their income tax liability.

Increased Expensing Limits Under Section 179 Made Permanent

The increased expensing limit and phase-out threshold under section 179, $500,000 and $2 million, are now permanent. Those amounts had fallen to $25,000 and $200,000, respectively. Additionally, the extension bill permanently allows taxpayers to expense off-the-shelf computer software and qualified real property (i.e., qualified leasehold improvement property, qualified restaurant property, and qualified retail improvement property) under section 179, provisions that also lapsed at the end of 2014.

Bonus Depreciation For Qualified Property

The act extends bonus depreciation for qualified property placed in service over the next five years, subject to a phase-out schedule:

  • 50 percent bonus depreciation in 2015, 2016, and 2017
  • 40 percent in 2018
  • 30 percent in 2019

After 2015, the bill allows bonus depreciation to be claimed on qualified improvement property regardless of whether the property is subject to a lease, and removes the requirement that an improvement be placed in service more than three years after the building was placed in service.

We hope to see you at the Washington Conference in April where we’ll continue to make inroads with Congress to support the dental community and oral health.

minieast1On August 10th, 20 participants from 12 DTA member organizations converged in Baltimore to attend the “first” DTA Mini-Dental School East session held at the University of Maryland School of Dentistry. Created in response to popular demand for the program, the Mini-Dental School East was modeled after the “original” Mini-Dental program at the University of Colorado School of Dental Medicine that DTA Members have been attending since 2003.  The two day sessions provide insights into the knowledge and skills that dental professionals receive in dental school with an emphasis on hands-on learning experiences. 

Continuing the focus and efforts of the 2015 DTA Future Trends Forum The Dilemma and Impact of Gray Market Product Sales, the July/August issue of Apex 360 magazine features a 23 page special report titled The Dental Gray Market.  As well as succinctly defining the Dental Gray Market in its various forms and levels, it also includes input from a diverse panel of industry experts representing manufacturing, distribution, dental laboratories  and the Dental Trade Alliance.  Contributors included DTA Executive Director, Gary Price, Vice President of Marketing/Merchandise for Patterson Dental, Tim Rogin, International Vice President for 3M ESPE, (and Future Trend Forum panelist) Simon Hearne, Chief of  Staff Executive of the National Association of Dental Labs, Bennett Napier, CAE, and Vice President and Director of Education at Marotta Dental Studio Inc., Steven Pigliacelli, CDT, MDT.

The current Apex 360 article not only provides a timely reminder to the growing issue of the Dental Gray Market and its impact on both the integrity of the industry and the ultimately safety of the public, but also provide insight into steps the dental industry has and can take to combat this issue.  You can click here to read the feature’s interview with Gary Price on the DTA strategy to address the issue of Gray Market as the voice of the dental industry.  To read the entire special report, go to http://www.dentistryiq.com/apex360-newsletter.html to sign in or to subscribe to Apex 360.

exportIntroduction to Sino–Dental Meeting in Beijing

June 2015 - The China International Dental Exhibition and Scientific Conference (Sino–Dental) in Beijing (every June) is a well–attended Chinese dental meeting. The Sino–Dental Meeting is celebrating its 20th anniversary this year.  It is managed by the International Health Exchange and Cooperation Center, National Health and Family Planning Commission and the Central Government of China. The recent Sino–Dental Meeting was held at the China National Convention Center (CNCC) in northern Beijing near the 4th Ring Road and Olympic Village.

Approximately 100,000 attendees visit the Sino–Dental Meeting. This includes nearly 60,000 dentists from Beijing and other sections of mainland China, with 700 companies exhibiting in 2015 including large German, Japanese, South Korean, Swiss and Chinese pavilions.  Many of the booths in the main exhibition hall are hosted by the local distributors who are authorized to sell these German, Swiss and even US devices.

There are a large number of scientific educational programs hosted by the Sino–Dental organizers and industry. A number of meetings and events take place during the Sino–Dental Meeting and in the evening immediately following the close of the exhibition. Nearby is the Olympic Village where the Chinese Olympics were held in 2010 including the famous Aquatic Center and the Bird’s Nest where the opening ceremonies took place.

DTA Members should review the new Hazard Communication Standard Final Rule to be sure that all applicable labeling and Safety Data Sheets are fully compliant for the June 1 and December 1, 2015 deadlines.

Hazard Communication Standard Final Rule:   New changes to the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard are bringing the United States into alignment with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), further improving safety and health protections for America's workers. Building on the success of OSHA's current Hazard Communication Standard, the GHS is expected to prevent injuries and illnesses, save lives and improve trade conditions for chemical manufacturers. The Hazard Communication Standard in 1983 gave the workers the ‘right to know,' but the new Globally Harmonized System gives workers the ‘right to understand.'

 

Written by DTA Regulatory Consultant, Blix Winston.

Recently, DTA met with FDA staff who went into detail about 510(k) applications that result in refuse to accept (RTA) letters—more than 60% of all applications receive RTAs—and found out what members can do to avoid receiving a rejection.

One of the ways to avoid receiving an RTA letter is to include an annotated copy of the RTA checklist with your application, to help FDA find each required item. However, even when an applicant does this, there are still pitfalls that cause applications to be rejected. 

Written by DTA Regulatory Consultant, Blix Winston.

As you’re probably aware, 510(k) review procedures have changed.

If you receive a refuse to accept (RTA) letter, it will be accompanied by a copy of the checklist indicating the deficiencies. You have 60 days to respond and send in the needed information. After that time, your application will be deleted. If this happens, your user fee has not been used up and can be applied to the next submission. 

Pages