The U.S. Food and Drug Administration (FDA) has warned Abiomed Inc. that its Impella Connect System is a device that is subject to the premarket approval (PMA) process and that the company failed to secure this approval. Therefore, according to a Sept. 19 warning letter from FDA’s Division of Medical Device and Radiologic Health Operations East to Andrew Greenfield, the president of Abiomed, the Impella Connect System is “adulterated.” FDA posted the warning letter on its website Tuesday. The letter says the agency made this determination based on an inspection of Abiomed’s location in Danvers, Massachusetts, which took place from March 1 through April 13. The warning letter was issued after Abiomed sent responses on May 3, June 19, Aug. 3, and Sept. 8 to concerns raised by FDA inspectors. The Impella Connect System is a web-based user portal with a remote link module that works with the Automated Impella Controller (AIC), which is part of the Impella mechanical circulatory system devices used to provide ventricular support to patients in a critical care setting. The Impella Connect System works with Impella pumps, including Impella 2.5, CP, 5.0, LD, 5.5, RP and RP Flex. The system provides email notifications of alarms as part of remote monitoring of the Impella pumps used in patients. These alerts allow users to “remotely monitor the performance of an individual AIC pump or multiple pumps and view case information on demand, as well as to filter notifications by alarm status,” according to the letter. “These features are software device malfunctions requiring premarket authorization because the notifications and view of the active AIC case status provide patient-specific medical information to detect a life-threatening condition and generate time-critical alarms intended to notify a health-care provider,” the warning letter says. “These are functions that meet the definition of a device.” Jenny Leary, the associate director of U.S. communications for Abiomed, said in response to an emailed request for comment from CRTonline.org that the Impella Connect System is an app that “does not affect the function of the pump.” She noted that regulations surrounding medical software device functions “are evolving.” “We are working closely with the FDA to fully resolve the observations as quickly as possible,” an Abiomed statement provided by Leary reads. “As we continue to integrate into Johnson & Johnson MedTech, we are implementing quality system process improvements related to the observations, and many of these corrective actions are already in process. “We are dedicated to the mission of providing safe and effective life supporting heart pump technology to patients worldwide, and Impella heart pumps remain on the market and available for patients in need.” Johnson & Johnson completed its acquisition of Abiomed in December. The FDA issued a guidance document called “Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff,” in September 2022 that provided the agency’s latest thinking on when medical software is a device that is subject to FDA oversight. Agency’s analysis of Abiomed’s response In a response dated May 3, Abiomed told the agency that the functions of the Impella Connect System are non-device clinical decision support software and non-device medical device data systems as described in the Federal Food, Drug and Cosmetic Act and therefore not subject to FDA regulation. The warning letter notes that the agency disagrees with this claim because the system’s alerts do not “support or provide recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition.” Rather, the email notifications of alarms “provide patient-specific medical information to detect a life-threatening condition and display time-critical alarms intended to notify a health-care provider, which are functions that meet the definition of a device and under the Act and therefore require premarket authorization,” the letter states. The letter goes on to explain that the notification requirement of a device requiring premarket approval “is deemed satisfied when a PMA is pending before the agency.” Because Abiomed has not received premarket approval or an investigational device exemption, the warning letter says the Impella Connect System is “adulterated” under the Federal Food, Drug and Cosmetic Act. The warning letter also cited instances in which formal recall or corrective action plans were not implemented in response to complaints received of possible device malfunction, including those possibly caused by user error, rendering the company’s devices “adulterated.” The FDA also said the Impella pumps are “misbranded” under the Federal Food, Drug and Cosmetic Act because Abiomed did not submit these required reports for complaints of which the company became aware in 2020, 2021 and 2022 until during the FDA’s inspection of the company’s facilities in March 2023. Image Credit: Tada Images – stock.adobe.com