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LMT Communications, Inc. wrote an article
Cc: 14 peopleAll-ceramics, implants, profit erosion and other hot topics inspired dialogue during the biggest weekend of the year.
Top Industry Trends at LAB DAY Chicago
LMT Communications, Inc. · Apr 2013>LMT magazine's LAB DAY in Chicago is the industry's educational superdome and the place for product launches and breaking news in the U.S. This year, more than 3,100 attendees from 47 states and 49 countries came to learn about new techniques, shop for the latest products, and meet up with their peers...
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LMT Communications, Inc. wrote an article
REGULATORY UPDATE: What You Need to Know About OSHA, FDA and the Medical Device Tax
LMT Communications, Inc. · Apr 2013At the Cal-Lab Meeting in Chicago, Safelink's Gary Morgan, CDT, offered an update on various regulatory issues, including OSHA, the FDA and the Medical Device Tax. Here's an overview: OSHA has revised...
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LMT Communications, Inc. posted a newsbrief
NADL Releases Guidebook For Medical Device Excise Tax
LMT Communications, Inc. · January 31, 2013In December, the IRS released its final rule on the Medical Device Excise Tax (MDT), determining that only those devices required to be listed with the FDA are subject to the tax (for example, sleep apnea...
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Miriam Olsen posted about Medical Device and Excise Tax
"Medical device"? Why isn't a shoe considered a medical device?
If a crown is considered a "medical device" why isn't a shoe considered the same? Will we get to the...(more)
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The Daily Bite
It's far more cost effective to keep existing clients than to replace them so knowing your client retention rate and tracking changes in their monthly spending patterns are critical. The easiest tracking method is to compare each client’s current month sales to his three or four rolling month overage.
LMT Original Research © 2010 - 2013
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New Healthcare Law Includes Excise Tax On Restorations
LMT Communications, Inc. · Industry News · Jun 2010
The NADL's analysis of the new healthcare legislation reveals a 2.3% excise tax applicable to the selling price of completed dental restorations.
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Attention Laboratory Owners: You Remain On the FDA's Radar
LMT Communications, Inc. · Industry News · Jun 2010
While the FDA is paying unprecedented attention to the dental laboratory industry, only half of laboratory owners and managers are familiar with the agency's Good Manufacturing Practice requirements.
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2.3% Excise Tax Goes Into Effect in 2013; FDA Registration Fees Increase
LMT Communications, Inc. · Industry News · Sep 2012
2.3% Excise Tax Goes into Effect in 2013; FDA Registration Fees Increase Since the Health Care and Education Reconciliation Act was signed into law in May 2010, laboratory owners have been wondering...See more whether the 2.3% excise tax on medical devices applies to dental restorations. Despite the efforts of the U.S. House of Representatives, NADL, ADA and nearly a dozen other allied dental organizations to have dental devices excluded from the tax, the IRS denied the request at a public hearing in Washington D.C. in May. "Effective January 1, 2013, it's prudent for dental laboratories to be prepared for remitting a 2.3% excise tax on sales of finished devices," says Bennett Napier, CAE Executive Director, NADL. According to an analysis by Reed Smith, LLP, the NADL's Washington, D.C.-based law firm: - The tax applies to the finished device rather than components. For example, if Laboratory A outsources a partial framework to Laboratory B, there would be no tax due on the transaction. The tax only applies when Laboratory A delivers the final case to the prescribing dentist. - For imported restorations, the importer—meaning the U.S. agent for the foreign laboratory, or the domestic laboratory or dental practice that sent it directly overseas—is responsible for paying the tax. - Restorations fabricated in the dental office, including those fabricated via chairside milling systems, are also subject to the excise tax. In terms of administrative filing, laboratories will have to use Form 720 which is available at www.irs.gov to report and pay the tax. This form has to be filed quarterly and then a final Form 720 is submitted at the end of each year. Form 720 includes sections that help your accountant or bookkeeper determine your tax liability for each quarter. For more information, click this link, www.irs.gov/irb/2012-13_IRB/ar12.html ###FDA Fee Increase In August, the FDA released new requirements for the registration and listing of medical devices, including dental devices, that take effect on October 1, 2012. Among the changes: - For labs that undertake a business activity that requires it to register with the FDA (see "Who Needs to Register with the FDA" below), the registration fee has increased from $2,029 to $2,575; this increase applies to both domestic and foreign laboratories. - If you import, your business activity in that arena will become public record on the FDA website as foreign establishments must now identify their U.S. lab and dentist customers, even those who send work through a U.S. agent or broker. "It's apparent this is an attempt by FDA to identify all entities in the U.S. that are importing and/or using devices from foreign establishments. This change significantly increases the transparency of entities that are doing any work offshore," says Napier. - The fee for filing a 510(k) form—required from labs that manufacture certain devices, like sleep apnea—has increased from $2,024 to $2,480; this is the fee for a small business with $100 million or less in sales. Filing this form also requires you to provide a website address. "FDA has been securing information from websites and apparently has been checking for 510(k)s on certain devices branded by the lab," says Napier. "If you don't have a 510(k) on the product, you shouldn't show that it treats any type of medical condition, symptom, disease or disorder such as sleep apnea. If you make a claim for treatment, then you must either file a 510(k) on the device yourself or ensure that the Manufacturer/Specification Developer has a 510(k)." - A lab that registers as a Manufacturer, Contract Manufacturer or Repacker/Relabeler must now identify any proprietary or brand names of the products (i.e. TAP III). Foreign operations must also now identify any proprietary names of the devices they manufacture. For a complete summary of the requirements, click this link, www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm ###Who Needs to Register with the FDA? The rules dictating who must register with the FDA remain unchanged and include: • All domestic and foreign laboratories that repackage or relabel restorations or material, including those who work through a U.S. broker or agent; domestic labs that import devices from a foreign laboratory; or domestic labs that fabricate sleep apnea or snoring devices (or any other medical device that is not part of the core dental lab function). • All foreign dental laboratories shipping into the U.S. • All U.S. brokers or agents for foreign dental labs shipping into the U.S. ### To see past coverage of this topic, click on the links below: [New Healthcare Law Includes Excise Tax On Restorations, June 2010](/articles/581) [Attention Laboratory Owners: You Remain On the FDA's Radar, June 2010](/articles/582) [To see all conversations and activity related to Excise Tax, click here.](/topics/3515)
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Tax: a 'Four-Letter Word' . . . With a Deficit
Judy Fishman · The Way I See It · The Way I See It · Oct 2012
It would be downright silly to suggest anyone actually likes taxes so it's no surprise that a coalition of 400 medical device manufacturers voiced its opposition to the 2.3% excise tax on medical...See more devices slated to go into effect January 1, 2013.
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Top Industry Trends at LAB DAY Chicago
LMT Communications, Inc. · LAB DAY · Apr 2013
All-ceramics, implants, profit erosion and other hot topics inspired dialogue during the biggest weekend of the year.
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NADL Releases Guidebook For Medical Device Excise Tax
LMT Communications, Inc. · Industry News · January 31, 2013
In December, the IRS released its final rule on the Medical Device Excise Tax (MDT), determining that only those devices required to be listed with the FDA are subject to the tax (for example, sleep apnea...See more and snoring devices as well as all restorations fabricated outside of the U.S.). To provide labs with a clear understanding of the MDT, the NADL has prepared a Medical Device Excise Tax Guidebook which includes an overview of the tax; the definition of a taxable medical device; key factors for manufacturer and importer determination; and a computation of the tax due to the IRS. The guidebook also covers sale and sale price; tax-free sales for export and further manufacture; and the final IRS rule along with IRS Notice 2012-77 and the interim rules. Electronic manuals (on CD) are available to NADL members for $50 each and to non-members for $250; printed copies are $75 for members and $300 for non-members. To order the guidebook, visit www.nadl.org.










