FDA已於2015年8月13日起要求製造商及進口商對不良事件通報需透過”電子”系統。
On Feb. 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. User facilities can also submit eMDR reports, but the final rule allows user facilities to continue to submit paper MDR reports.
Manufacturers and importers had until Aug. 13, 2015 to begin submitting all MDR reports electronically. If a manufacturer or importer was unable to meet this date, they must request and obtain an exemption from electronic reporting to continue to report via hardcopy past Aug. 13, 2015.