Dental Laboratories - 3D Printing of PPE, an FDA Compliance Panel Discussion

This webinar will cover key issues related to dental laboratories who are trying to help the country in a time of need with COVID-19 by 3D printing PPE for the health care supply chain.

Depending on the type of device, there are different U.S. FDA requirements and compliance for manufacturers of PPE. Some PPE is Class I and some is Class II. For dental laboratories that are not already registered with FDA printing some PPE may require FDA registration. There may also be additional quality system measures that come with printing PPE in mass quantity as well as labeling requirements depending on the distribution channels being used.

The FDA provides some guidance at https://www.fda.gov/medical-devices/3d-printing-medical-devices/faqs-3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic.

Requirements for Course Completion

Participants will view the one-hour video and complete a short test. Participants must correctly answer at least 80% of the test questions to receive credit. If a grade of at least 80% is not achieved, the test may be repeated two times.

Accreditation

Upon successful completion of this course, participants will receive one hour of Regulatory Standards through the National Board for Certification in Dental Laboratory Technology (NBC).