FDA 483 - Aeye Health Inc. - March 15, 2024

Aeye Health Inc., a medical device manufacturer in New York, NY, received a Form FDA 483 for failing to maintain written Medical Device Reporting (MDR) procedures. The firm specifically lacked electronic Medical Device Reporting (eMDR) procedures and had not established an Electronic Submissions Gateway (ESG) account. These deficiencies are critical as they prevent the proper handling of reports for serious injuries and deaths related to their medical devices.