The US Food and Drug Administration (FDA) recently sent a warning letter to Abiomed. The heart pump company, owned by Johnson & Johnson, failed to get approval for patient monitoring software before selling it.
This is the latest example of the agency standing on to its last year’s promise to closely regulate software embedded in medical devices.
What has Abiomed done wrong? How is the FDA regulating the rapidly evolving digital health sector?
Let’s dive deep into today’s article to find out.
FDA’s crackdown on Abiomed
Abiomed, a cardiovascular device manufacturer, is popular for its Impella heart pump platform. Johnson & Johnson acquired the company for $16.6 billion last year. Here’s why the FDA has issued a warning letter to the company:
Failure to gain PMA approval
The company is developing Impella Connect, which comprises an Impella heart pump and clinical support software to assist heart pumping in critical care settings. While the heart pump is FDA-approved and available in the market, the clinical decision software with remote monitoring capabilities is currently under clinical trials.
Last year, the FDA reframed regulations, making it mandatory for such software embedded in medical devices to gain pre-market approval (PMA). However, Abiomed failed to submit the data for PMA before marketing it to the public and is in a tight spot.
Irregularities with the heart pump
The FDA has also mentioned irregularities with the heart pump in the warning letter. The agency has received several complaints against Abiomed Impella heart pumps, including problems like purge fluid leaks, blood clots and motor damage.
The company has failed to adequately investigate these issues and report them to the FDA as a part of postmarket surveillance. It also failed to recall the distributed devices based on risk to health.
Inadequate quality management system
The FDA has also pointed out that the Abiomed quality management system is plagued with issues and is inadequate in ensuring the safety and effectiveness of its products. The warning letter states that the company has failed to establish and maintain procedures for receiving, reviewing and evaluating complaints about its medical device.
Way forward for Abiomed
The FDA has asked Abiomed to submit data for premarket approval through formal steps and wait for its decision as to whether the product can be legally marketed. The agency has also asked the company to submit a corrective market plan to ensure the safety of its device and technology.
The FDA has suspended Abiomed’s ability to market its clinical decision software until it has addressed the FDA’s concerns.
“Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
–FDA warning letter
Abiomed has acknowledged the FDA’s findings and has pledged to take corrective action. It has stated that the software doesn’t affect its pumps and that the heart pumps are safe to use and approved by the FDA.
Furthermore, the company has stated its commitment to working with the FDA and ensuring the safety and effectiveness of its devices and technology.
“We are working closely with the FDA to fully resolve the observations as quickly as possible. 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.”
–Abiomed
What does the FDA’s crackdown mean for other digital health companies?
FDA’s crackdown on Abiomed is only the latest example of its regulatory tightening. Earlier in July, the agency had sent a similar scrutiny warning letter to iRyhtm, a heart monitoring company. This is an indication of the increasing scrutiny of clinical decision support tools by the FDA.
As machine learning and generative AI are rapidly being adopted in the healthcare industry, the FDA is tightening the rules to ensure their safety and efficacy.
The agency also plans to issue final guidance on how companies should manage AI and draft guidance on premarket submissions and life cycle management for companies selling devices embedded with AI and machine learning during the 2024 fiscal year.
The FDA’s warning letter to Abiomed serves as a reminder to all medical device manufacturers to stay updated with the FDA’s guidelines and comply with the latest regulations to ensure the safety and efficacy of their devices.
