A Q&A WITH FDA

NADL sat down with the Food and Drug Administration in spring 2021 to ask some of the most common questions we receive from our NADL Members.  Some of these questions include:

  1. How are dental laboratories exempt from FDA registration pursuant to the exemption found in 21 CFR 807.65(i)?
  2. What are some common examples of activities that are outside of the exemption that would require a dental laboratory to register as a medical device establishment?
  3. Can you discuss the importance of a validated process for a CAD/CAM abutment system used by a dental laboratory?
  4. Can a dental laboratory print a model within the registration exemption?
  5. What are the current trends and anticipated trends going forward regarding the inspections of dental laboratories?

Accreditation

Due to the short length of this video, this course is not approved for credit through the National Board for Certification in Dental Laboratory Technology (NBC).