In August 2012, the U.S. Food and Drug Administration released new requirements to the registration and listing of medical devices including dental devices that took effect Oct. 1. There are changes that could affect you.
Even dental laboratories that are not currently required to register with the FDA, but do business with entities who are registered (or should be registered) with FDA or manufacture products that are registered with FDA, may be affected by these changes.
The October Journal of Dental Technology will feature an in-depth article that summarizes the requirements based on the type of medical device establishment required to register and list.
However, here’s the take away:
- If you register, you will pay a fee.
- Along with listing codes for your products, you will also list proprietary names of the products, if any.
- If you import, your business activity in that arena will become public record as foreign establishments must identify their customers.
Also, when you register you are required to provide your website address. FDA has been securing information from websites and apparently has been checking for 510(k)s pre-market approvals on certain devices that are branded by the dental laboratory. If you don’t have a 510(k) on the product, then you shouldn’t show that it treats any type of medical condition, symptom, disease or disorder such as sleep apnea. If you make a claim for treatment then you must either file a 510(k) on the device yourself or ensure that the manufacturer/specification developer has a 510(k). The fee to register a product through the 510(k) process is $4,960, or $2,480 for small businesses, which are defined as having $150 million or less in sales.
It’s apparent from these changes that the Food and Drug Administration is serious about tracing the entities in the U.S. who are importing from other countries. What does this mean to you? If you are importing, then dot your I’s and cross your T’s through an effective quality system that meets FDA’s quality system regulation.
For more information, visit http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm.