Risky Business: FDA Registration Fact or Fiction
Looking back over the past year, it appears that the most misunderstood issue for dental laboratories regarding compliance with FDA was and still is: Who has to register with FDA? And for those dental labs that do have to register the other question is “How do I register and as what?”
I’ll begin by stating that this isn’t a simple issue to address. Part of the confusion begins when you call FDA to ask the question but you may only state that you are a dental laboratory. Their answer would most likely be that according to the regulations dental laboratories are exempt from registration. You like that answer so you don’t register nor do you explore the issue any further until you hear that a colleague had to register his or her laboratory or a speaker or manufacturer informs you that there are certain criteria that trigger registration for a dental laboratory.
So, here’s an explanation about registration that hopefully is helpful to you. I preface this, however, by stating that you need to use this information along with the advice of FDA and/or other experts to determine if and how you should be registered with FDA.
First let’s take a look at the exemption for dental laboratories which is in Part 807 and specifically item (i) of Subpart D of Title 21-Food and Drugs, Chapter I-Food and Drug Administration, Department of Health and Human Services, Subchapter H-Medical Devices:
“PART 807 -- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
Subpart D--Exemptions
Sec. 807.65 Exemptions for device establishments.
The following classes of persons are exempt from registration in accordance with 807.20 under the provisions of section 510(g)(1),(g)(2),and (g)(3) of the act, or because the Commissioner of Food and Drugs has found, under section 510(g)(5) of the act, that such registration is not necessary for the protection of the public health. The exemptions in paragraphs (d),(e),(f),and (i) of this section are limited to those classes of persons located in any State as defined in section 201(a)(1) of the act.
(a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part.
(b) A manufacturer of devices to be used solely for veterinary purposes.
(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.
(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.
(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating "distributed by" or "manufactured for" followed by the name of the pharmacy.
(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.
(g) [Reserved]
(h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers.
(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic x-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.”
So what would change the above exemption and require a dental laboratory to register with FDA? The following chart indicates the activities that would place a dental laboratory in a position of having to register with FDA:
Manufactures a custom device - Even though you consider yourself as the manufacturer of a custom device, the typical appliances manufactured by dental laboratories do not fall into this category therefore most domestic dental labs would not register as a manufacturer. There are situations, however, where a dental laboratory in the US would register as a manufacturer, i.e. if they own a patented device.
Relabeler or Repackager - If you import dental devices such as PFM’s dentures and upon receipt you remove them from the foreign lab packaging and place them into your packaging with your name, then you must register as a Repackager/relabeler. If you take an order from a dental client for a sleep apnea device or snore guard but have another dental lab manufacture the device for you and upon receipt you place the item into your packaging with your name on it, then you must register as a Repackager/relabeler. There is no fee for this type of registration.
Contract manufacturer who commercially distributes the device for the specifications developer - If you manufacturer a sleep apnea device or snore guard, then you must register as a Contract Manufacturer. Currently the fee for this type of registration is $2,179.00 and seems to increase each year.
Initial Distributor/Importer - If you ship direct to a foreign dental laboratory and receive your appliances direct from the foreign dental lab, then you must register as the Initial Importer. There is no fee for this registration. If you go through a corporation in the US that is receiving your work, shipping it to the foreign lab, receives the work from the foreign lab, and then ships it to you, then you wouldn’t register with FDA. You want to be sure, however, that the corporation in the US is registered with FDA.
Foreign Manufacturers - Must register – typically as a Manufacturer and must pay a fee. You must only do business with a foreign manufacturer who is properly registered with FDA.
Once you have determined if you fall into any of those categories, then you must determine the product codes for the products that you will show on your registration. With the exception of the initial distributor/importer, you will need to list product codes. The best advice we can give you on this is to go to FDA’s Web site to determine the correct product codes. Ha, ha! This isn’t always an easy task either.
Some of the most common dental laboratory FDA Product Codes are:
LQZ-Device, Jaw Repositioning: 872.5570 Class II Device
LRK-Device, Anti-Snoring: 872.5570 Class II Device
OCO-Mouthguard, Migraine/Tension Headache:
KMY-Positioner, Tooth, Preformed: 872.5525 Class I Device
NSJ- Restoration, Noble Metal:
NSK- Dentures, Partial: NSL- Dentures, Full:
NSM- Restoration, Resin:
NSN- Restoration, Resin, Crown and Bridge:
NSO- Restoration, Porcelain-Fused-To-Metal:
NSP- Restoration, Porcelain:
NSQ- Restoration, Base Metal:
NSR- Prosthesis, Orthodontic:
The product codes with the first letter of “N” are the products manufactured by foreign labs so the foreign lab registering with the FDA would use those codes.
The following Web link will take you to the FDA’s registration information:
http://www.fda.gov/cdrh/registration/furls.html Here are some reminders that are posted on the FDA Web site regarding registration:
All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31. Note from SafeLink: Be sure to mark your calendar to renew your registration. FDA does not typically send out a renewal notice. We had a number of calls in the last days of 2010 from labs trying to renew their registration so don’t wait that long. Also make sure you keep your sign-in password info handy as that can delay your renewal at the end of the year.
FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process.
FDA is aware that some browsers, and equipment may not operate correctly with our system. These include MAC personal computers, Internet Explorer 8.0, wide screen monitors, and browsers such as Firefox or Google browser (CHROME).
FDA communicates with registered medical device establishments by email. In order to receive electronic communications from FDA, be sure to set your spam filters to accept email from any @fda.gov email address.
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Author Information
Mary Borg
