FDA presentation on Medical Device Reporting (MDR) Reporting Requirements
Published on: Wednesday, April 17, 2024
The U.S. Food and Drug Administration (FDA) presented “Medical Device Reporting (MDR) Reporting Requirements” to the Organ Procurement and Transplantation Network (OPTN) committee members on Feb. 5, 2024.
The presentation was provided by Dr. Vaishnavi Chandrasekar, MDR Analyst and Lead Reviewer for the Renal and Transplantation Devices Team in the Center for Devices and Radiological Health at FDA. The presentation focused on required reporting of adverse events related to malfunctioning or defective medical devices. Such devices include perfusion or preservation devices used in heart, kidney, liver, and lung transplantation.
This information has broad application to organ donation and transplant clinicians. A recording of the webinar is available below.
OPTN members have often reported these events to the OPTN, commonly through the Patient Safety Portal. However, OPTN members should directly report these events to the FDA through either of these two links:
- https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
- http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm