FDA Workshop: Orthopedic Device Postmarket Review

Virtual Conference
June 21, 2021

FDA Workshop: Orthopedic Device Postmarket Review

This Food and Drug Administration (FDA) virtual public workshop is intended to enhance public understanding of FDA’s postmarket activities related to the regulation of orthopedic devices under 21 CFR Part 888.

The purpose of the workshop is to share information with stakeholders, including members of the orthopedic community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public, on FDA regulations, guidances, and programs related to orthopedic device postmarket activities and challenges that are commonly faced in this area.

Topics will include:

* Recall and Medical Device Reporting

* Post Approval and Postmarket Surveillance Studies

* Inspections and Postmarket Approval Reporting