Public Workshop - Spinal Device Premarket Review - 08/13/2020 - 08/13/2020 | FDA

Public Workshop - Spinal Device Premarket Review - 08/13/2020 - 08/13/2020 | FDA

Public Workshop: Spinal Device Premarket Review

The U.S. Food and Drug Administration (FDA) is announcing a public workshop on Spinal Device Premarket Review, which will be held on August 13, 2020. During the workshop, the FDA will share information about the spinal device premarket review by highlighting key sections of a premarket notification (510(k)) submission with stakeholders including members of the orthopedic community, device manufacturers and industry consultants.  The FDA will also discuss product specific and general guidances with stakeholders to help improve submission quality and efficient review of orthopedic spinal device premarket applications.

Learn More and Register

Meeting Details: Date: August 13, 2020 Time: 8 a.m.–5 p.m. ET Location: Webcast Only Registration: No fee for registration. Registration is required by August 3, 2020 Questions? If you have questions about this public meeting, contact the Division of Industry and Consumer Education.