Sleep Apnea

More news on the Excise Tax: As reported in an earlier post, the only dental restorations that are subject...See more to the new 2.3% Medical Device Tax are those that are required to be listed as a device with the FDA (including sleep apnea and some orthodontic devices). However, according to the NADL, the tax will also apply to two other areas�"imported restorations and raw materials�"since both are required to be listed as devices with the FDA and therefore become a taxable medical device under the IRS rule.

This means that the importer of restorations made by foreign laboratoriesâ€�"meaning the domestic laboratoryâ€�"will be responsible for reporting and remitting the tax. In addition, manufacturers and suppliers are also subject to the tax on the sale of raw materials like alloys and ceramics. “Dental laboratories will likely see increased costs of goods due to the need for suppliers and manufacturers to pass on the costs of the tax,” says the NADL’s Bennett Napier, CAE. “Dental laboratories still need to understand and be prepared to mitigate the impact of the excise tax as it still will have a significant impact relative to overall operating expenses.” — tagged Excise Tax and Medical Device

The NADL has announced that the IRS's Final Rule on the Medical Device Tax released on December 4th confirms...See more that the 2.3% excise tax will NOT apply to most domestically made dental restorations.

According to the NADL, which has dedicated an enormous amount of time and resources to researching and analyzing the tax implications, the only domestically made dental devices subject to the new tax are those currently required to be listed as a device with the FDA, including sleep apnea and some orthodontic and implant devices. "This is good news for most domestic dental laboratories since most of them manufacture devices that are not required to be listed with the FDA and consequently won't be subject to the Medical Device Tax," says Bennett Napier, CAE, NADL Executive Director. — tagged Excise Tax and Medical Device

Heads up. FDA Regulation changes - you could be exposed because of your dental laboratory website.

Reading...See more through the last post from Bennet Napier and this caught my attention:
"Also, when you register you are required to provide your website address. FDA has been securing information from websites and apparently has been checking for 510(k)s pre-market approvals on certain devices that are branded by the dental laboratory. If you don’t have a 510(k) on the product, then 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). The fee to register a product through the 510(k) process is $4,960, or $2,480 for small businesses, which are defined as having $150 million or less in sales."
Ref: http://www.jdtunbound.com/unbound-exclusive/september/2012/new-fda-regulations