The FDA has made several changes in firm registration and device listing. Perhaps the biggest change is that companies are now required to register (FDA Form 2891) and list (FDA Form 2892) online (unless FDA grants a waiver) and pay a registration fee every year.

To perform these required actions, and to learn more about the subjects, all device firms are advised to go to the registration and listing home page: www.fda.gov/cdrh/reglistpage.html. In addition to registration and listing forms, this "reglist" page provides links to pages that tell you who must register and list, when and how to register and list. It is a library of information. This page has links that will provide answers to most registration and listing questions. Also, DSMICA (Division of Small Manufacturers, International and Consumer Assistance) has recently mailed an official notice, with explanations, to registered firms, listing the new User Fees for fiscal 2009. If your company needs further information, you can call DSMICA at 800-638-2041 or by email at dsmica@fda.hhs.gov or contact reglist@cdrh.fda.gov. Incidentally, the CDRH home page address is www.fda.gov/MedicalDevices/default.htm.

We all have a tendency to look askance at many government "improvements." Except for the small detail that eventually proper coordination of these forms will point the FDA to those firms that should have but didn't file required 510(k)s, the down-side of these developments is quite limited. One of the reasons for this is that a large proportion of dental devices have been placed in Class I, exempt from 510(k)s. Please note: these exemptions do not apply to Listing! These low classifications and many exemptions are largely the result of efforts of DTA's predecessors, ADTA and DMA.

Because it has been years since a list of 510(k) exempt dental devices has been available, we have linked one for your convenience. We hope you will find this list useful.^* This list also is very helpful in Listing your devices. The one piece of information that many firms lack for filling out the listing form is the "Product Code", a 3-letter Code that describes a given device, and which is shown on that exemption list. This "code" provides a major link in 510(k) searches. The product Code also can be found on the FDA Classification data base, for which there is a link on the reglist homepage.

Those who are used to looking at registration and listing forms will find some real changes in the latest versions. Please note that when you fill out a listing form, it provides you with four unique Listing Number(s). Old forms had only one preprinted Listing number. We have found the Registration and Listing Staff quite helpful in case you have problems. (reglist@cdrh.fda.gov)

A reminder to medical device firms - registrations must be updated every year. The announced fee for fiscal 2009 is $1,851 which is due between October 1, 2008 and December 31, 2008. Unlike the Premarket Application Fees, which have a reduced fee for small businesses, there is no reduction in registration fees for small business registrations.

A distinct change is that companies cannot register until they have paid their User Fee. A small consolation to firms who file a premarket notification 510(k), the user fee has been decreased slightly to $3693 for this fiscal year.

One major point: in order to register (or list) a device, companies must establish an "account" by establishing a Password to go along with an Official Correspondent’s name and Firm Name. To establish an account, go to the secure FURLS system. https://www.access.fda.gov.oaa The process is rather reasonable. Use of this system and account is also required for updating your registration and listing information.

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* Note: Some dental devices are also exempt from Good Manufacturing Practices (Quality Systems) regulations part 820 except for 820.180 (general records) and 820.198 (complaint files). These are indicated in the "GMP" column.