Disclosure, Registration and Regulations: What You Need to Know

The globalization of our profession and growth in outsourcing--both domestic and offshore--has raised a number of concerns among laboratory owners, one of which is the issue of disclosure. If you're using subcontractors--domestically or offshore--do you legally have to let your dentist-clients know where the case was made?

With the August 2005 passage of the Medical Device User Fee Stabilization Act*, Congress has answered this question, explained NADL Executive Director Bennett Napier during his presentation at the annual CAL-Lab Group meeting in Chicago in February. "If a medical device is not manufactured by you, you must identify it as such. So if the case is fabricated by another laboratory, you must either label it as "Manufactured by [Name of lab] and distributed by [Your Lab Name]" or just "Distributed by [Your Lab Name]," said Napier. "This applies to both domestic and internationally outsourced restorations."

Enforcement of this Act comes under the auspices of...