HSCA Submits Comments to FDA on Using Unique Device Identifiers in Medical Device Safety Communications to Support Accuracy, Quality, and Patient Safety
Washington, DC (January 19, 2021) – The Healthcare Supply Chain Association (HSCA) Committee for Healthcare eStandards (CHeS) today submitted comments to the U.S. Food and Drug Administration (FDA) encouraging the agency to use unique device identifiers (UDI) to improve FDA communications regarding the safety of medical devices.
Patients across the country rely on medical devices in their day-to-day lives, and timely, informative communications in the event of medical device issues are critical to patient care. The FDA solicited feedback from healthcare stakeholders on ways to strengthen the agency’s medical device safety communications to help support patient safety.
“The ability to track and recall medical devices when issues arise is critical to protecting patients, many of whom depend on medical devices,” said Curt Miller, Executive Director of CHeS. “Incorporating UDIs into all FDA data sets, submissions, and communications will enable healthcare stakeholders to quickly identify and withdraw relevant products and improve overall accurate identification and traceability while promoting patient safety.”
Click here to read the full release.
Click here to read the full comments.
Comments of the Healthcare Supply Chain Association (HSCA) on USTR Request for Comments on the Proposed Modification of Action Pursuant to Section 301
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the...
Comments of the Healthcare Supply Chain Association on USTR Request for Comments on Additional Tariff Exclusions for COVID-19 Response
Dear Ambassador Lighthizer: On behalf of the Healthcare Supply Chain...