FDA Medical Device Registration Requirements

Bennett Napier (BN): Laboratories doing work for their doctors only, and not importing cases directly or indirectly from foreign laboratories, do not need to register with the FDA. Under the Code of Federal Regulations, dental laboratories are exempt from registering with the US Food and Drug Administration; however, all dental laboratories are subject to compliance with FDA quality system/good manufacturing practice regulations and are subject to inspection by the FDA.

However, there are specific activities that do affect the exemption from registration with the FDA. Dental laboratories that perform the activities listed below do have to register with the FDA. You may fall into more than one category, however, you only pay one annual fee to the FDA regardless if you have to register under more than one category.

• Sleep apnea/snore guards of someone else’s design or a 510K registered product—Register as a contract manufacturer and potentially a remanufacturer/relabeler
• Sleep apnea/snore guards of your own design—Register as a manufacturer
• Import directly from a foreign dental laboratory—Register as an initial importer
• Import indirectly from a foreign dental laboratory—Register as a remanufacturer/relabeler
• Serve as the customer service division that handles complaint resolution with customers (dentists or other dental laboratories) if you have another owned affiliate location in another geographic location that is registered with the FDA in another category—If a dental laboratory is “branding” a Class II implant abutment under its company or using a branded name, this also requires registration as a manufacturer. Branding crowns, bridges, dentures, inlays, and onlays in and of itself does not require registration.

CB: How about laboratories offering design services for other laboratories or for a dentist with chairside milling capability? And is registration required for milling centers and laboratories specializing in cast partial frameworks for other laboratories?

BN: This does not require registration if it’s domestic to domestic only.

CB: What is the FDA’s current position on custom implant abutments?

BN: The US FDA is potentially going to release a guidance document for dental laboratories that are selling custom implant abutments. This could impact most dental laboratories as most in some fashion are selling implants now. The guidance document will likely address protocols for laboratories that seek to override software protocols for angulation. If a dental laboratory is “branding” an implant abutment under its name, then that does trigger registration.

CB: Are only “registered” laboratories required to collect and remit the Medical Device Excise tax (on all products) or are all laboratories required to pay it?

BN: All dental laboratories, whether they are required to register with FDA or not are subject to reporting and paying the medical device excise tax. The tax applies to all establishments that manufacture and sell medical devices, regardless of the class of the device.

Taxable medical devices include dentures, bridges, implant abutments, crowns, inlays, onlays, veneers, orthodontic appliances, sleep apnea, etc. The tax also provides no exemption to dentists who have in house laboratories or manufacture devices using in office CAD/CAM. The tax is based on what is being manufactured and provides no exemption based on what setting the device is made in.

CB: I have heard that if a laboratory is selling a crown for under $150, then they are exempt from registration and having to collect the Medical Device Tax. Is this true?

BN: There is no exemption from registration based on gross sales or unit fees. If a dental laboratory is performing an activity that triggers registration, then they have to register. The FDA does offer a discount on the 510(k) process for businesses that have $150 million in gross sales or less a year, however, there is no discount on registration fees.

We have outlined above those items that are considered taxable medical devices. The Internal Revenue Service has not released its final rule that will implement the tax, which is based on the law passed by Congress and signed by the President in 2010. The final IRS rule will likely clarify ancillary services that are not taxable. NADL advocates that services related to manufacturing the device should not be taxable if they are not a part of the finished device, ie, shade verification, chairside consultation, creating the model, or bite rim. Again, that is NADL’s argument; it’s not definitive until there is final clarity from the IRS, which hopefully will be released by mid to late October 2012.

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