FDA Revises Medical Device Establishments Registration Fees and Requirements

摘要

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 following is the table that is a part of the Aug. 2, 2012 federal notice and summarizes the requirements based on the type of medical device establishment required to register and list. To assist you with interpreting this information, you'll see SafeLink Consulting's and the National Association of Dental Laboratories' comments in bold inserted into the table on how each requirement could affect dental laboratories.