New FDA Registration for Medical Device Manufacturers

[KatieKosty]

I haven't seen this posted yet-new FDA requirements for Medical Device Establishments

Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013

FDA Device Registration and Listing:



If you're going to apply for a 510K, you should first apply for a Small Business Qualification-it will save 1/2 the cost for your first 510K:

[URL="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf?source=govdelivery"]http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf?source=govdelivery

 

[Rayne]

Here is a link to 3 videos and some info on the Medical Device Tax from Bennet Napier from the NADL:

FDA Medical Device Registration Requirements - Inside Dental Technology - dentalAEGIS.com

It clears up some of the confusion about the tax and ways the tax can be reduced by factoring delivery cost.

If you don't know where to start or how you will implement the new Medical Device Tax, Evident dental laboratory management software is already developing the features needed to make this new tax compliance as easy as possible.

Keep in mind the new tax for US dental laboratories is effective January 1st 2013. If you're considering empowering your dental lab with Evident, best start sooner than leave it to December 30th.

 

[AJEL]

Rayne nice link you have the four videos Bennett Napier has so far on this sticky, curently partly defined situation. I am looking forward to seeing some more from NADL.
The facebook link has quite a bit to FDA Update: Medical Device Excise Tax | Facebook

Also another good facebook is Log In | Facebook

 

[evanosu]

So what if you outsource your C&B overseas and don't make any of the other devices that would classify. So basically Company A in Florida is the initial importer of my items (although it goes right to China) and then I get it. So do we still have to register or no?

 

[Tom Moore]

So what if you outsource your C&B overseas and don't make any of the other devices that would classify. So basically Company A in Florida is the initial importer of my items (although it goes right to China) and then I get it. So do we still have to register or no?

From what I understand this is why as the initial importer I must pay the tax based on what I sell it for plus sending in a list of my customers. Then those that resell will be known and be made to pay about $2300 a year to register as a repackage/relabeler but the dentist buying from me or a reseller for their own use is exempt.

 

[designasmile]

From an email

I have seen that information from Mary and from the FDA site. But, be careful, that is old information based on the statement that there is NO FEE for registering as an initial importer. That changed as of July, and requires the lab to pay $2575. No exemptions for labs that must register.



From my investigation, and communication with the FDA, NADL, and Customs, the only labs that won’t have to register are labs that make basic dental products domestically i.e. crowns, bridges, dentures. IF they import, make sleep apnea appliances, or anything Class II they will be obligated to register AND pay. And as far as offshore…the offshore lab is now required to provide the FDA with their customer list, which then goes into the data base, and no one can hide from the long arm of the law!

 

[Mark Jackson]

IF they import, make sleep apnea appliances, or anything Class II they will be obligated to register AND pay. And as far as offshore…the offshore lab is now required to provide the FDA with their customer list, which then goes into the data base, and no one can hide from the long arm of the law!

Type II medical devices include custom abutments for implants. FYI

FED EX is now segregating shipments for Dental Manufacturers into the medical device and health sciences area. No longer part of general freight. Hope everybody has their GMP's in place.

 

[JohnWilson]

I will bet if UPS doesn't follow suit that fedex will not gain market share in this industry.

 

[GAP]

Here is a link to 3 videos and some info on the Medical Device Tax from Bennet Napier from the NADL:

FDA Medical Device Registration Requirements - Inside Dental Technology - dentalAEGIS.com

It clears up some of the confusion about the tax and ways the tax can be reduced by factoring delivery cost.

Ok, so if I understand this correctly, I'd have to break it up on the invoice and charge out piecemeal....... How annoying.

So I'm guessing,
For the e.max Cr piece it would come to:
$29.00 for the material directly contained in the device (ingot, stains & glaze)

$.68 cents for the tax on the $29




PFM --The parts that would be taxable are
$.94 (NP Base alloy at $15/oz)
$1.74 (1.07g of porc for a 20g bottle at $33/bottle)
$1.50? (stains & glaze)
$4.18 for the materials directly contained in the device

$.10 cents for the tax

Am I missing something?

 

[Rayne]

The tax is based on the total amount the dentist is charged minus the products not included in the final product (e.g. model) and transport costs. Keep in mind this is still to be confirmed by the IRS this fall, but this is the info Bennet Napier has provided to us so far.

So for example:

Crown (all materials and processes included) $80.00
Chair side consultation $25.00
Delivery $15.00

Total $120.00

With the tax:

Crown (total cost minus model and transport) $80.00 - ($2.00 for model and $15.00 for delivery) = $63.00 x 2.3%
Chair side service not included in tax $25.00
Total tax = $1.45

New Invoice Crown with delivery and chair side consult = $121.45

Again, all of this needs to be confirmed and we will build in options into the Evident system to stylize the reporting and submission to reduce the amount of time dental labs spend on the new tax submission. The system will record automatically when you invoice with the new tax and provide the report needed to fill out the form 720.


Any thoughts or suggestions on what you want included are always welcome as our development comes directly from our users.

 

[lcsmith0000]

is no one upset about this new tax?

 

[Rayne]

The MDT has been enabled in the Evident system. It was a little bit of a journey due to some pivotal information being left out of the preparation notes like the retail discount of 25%. But all has been corrected and we now have Evident users MDT-ing to their hearts content.

What a ridiculous tax! I haven't seen a tax so complicated .... ever! The accountants are going to rack up the billable hours on that little gem. However, if you are looking to simplify the integration of the new tax AND reduce the number of billable hours for your accountant, Evident is ready for your lab. We tried to minimize the time required so as not to impact the production of the lab, which is the goal of any good lab management software.

If any one is interested, please don't hesitate to call. Happy New Year and all the best for 2013!

 

[shane williams]

Type II medical devices include custom abutments for implants. FYI

FED EX is now segregating shipments for Dental Manufacturers into the medical device and health sciences area. No longer part of general freight. Hope everybody has their GMP's in place.

That is only if you are milling out the entire abutment correct? Not if you use medentika, NT Trading or Glidewell's interface and mill out the zr and lute them together. Or would that process be considerd the same?

 

[VictoryDental]

Do we charge tax on relines and repairs etc?

 

[Rayne]

Do we charge tax on relines and repairs etc?

From what I've seen, the MDT is applicable to finished devices only, any services like repairs, relines, chair side consult etc are not included as you haven't produced the end product from basic materials. Also if your lab makes everything domestically then your exempt from the MDT - that's a good one to know.

 

[titaniumsupplier]

Keep in mind the new tax for US dental laboratories is effective January titanium plate 1st 2013. If you're considering empowering your dental lab with Evident, best start sooner than leave it to December 30th.

 

[MaxHickey]

Approval of FDA (Food and Drug Administration) is essential for commercializing any medical device in the US market. Your medical device usually categorized in three different classes such as Class I, Class II and Class III. Here are the requirements for FDA submissions:
1. If your device comes under the Class I category, it is not necessary to wait for FDA clearance; however, you have to meet all Class I FDA product registration needs.
2. Device under Class II category will have to make a 510(k) submission for fulfilling FDA device registration needs.
3. Class III device, the FDA submission should have Pre-Sub (Pre-IDE) and IDE consulting.