The FDA has just made several changes in firm registration and device listing this summer. Perhaps the biggest is that you can now obtain registration (FDA Form 2891) and listing (FDA Form 2892) forms on line. To do this, and to learn more than you may want to know about the subjects, go to www.fda.gov/cdrh/reglistpage.html. This page for registration and listing has links that can provide answers to most registration and listing questions.

The changes are a major step toward computer enabled completing and submitting these forms online, but the FDA hasn't gotten quite that far. However, you can obtain, and complete, both forms 2891 and 2892 online. You still have to sign and submit these forms by mail.

All device firms are advised to at least look at the registration and listing home page: www.fda.gov/cdrh/reglistpage.html. It is a literal library of information on the subject. If you are not quite that computer-comfortable, the forms are still available by calling the Registration and Listing staff at (240) 276-0111. Alternately, you can request the forms be mailed to you by e-mailing a request to reglist@cdrh.fda.gov or by selecting the "Contact Us" link on the page cited above.

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 also contains "Communications to stakeholders" which includes general information they think is necessary. The FDA refers to its costumers (you) as "stakeholders." One of these, "General Letter to all Establishments" is practically required reading by Official Correspondents.

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 the exemption list (attached) for your convenience. This "code" provides a major link in 510(k) searches. The product Code 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 firms will find some real changes in the latest versions. Please note that when you download 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. Good luck!

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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.