Imagine, if you will, an established medical device player and their newly-acquired subsidiary trying to flex their combined industry muscle by pushing back on an FDA warning letter regarding software used to manage an implantable heart pump.
You don’t need to read to the end to know how this will turn out, right?
This company may be an industry behemoth, but that doesn’t mean they don’t need to follow to rules.
It seems that last year, the company – who we’ll call Big MedDev – acquired the company that makes the heart pumps for a whopping $16.6 billion. The heart pumps were launched in 2021 and rely heavily on a web-based user portal and a remote link module to keep the heart pumping in a critical care setting.
Great idea, great technology, with just one minor flaw.
It seems the subsidiary company didn’t bother with a PMA, and THAT is the main bone of contention between Big MedDev and the agency – and the reason for the FDA warning letter.
The pumps have been subject to two recalls this year, with four deaths attributed to the device, never a good thing. The FDA warning letter stated “these notifications and view of the active AIC case status provide time-critical alarms with patient-specific medical information intended to trigger potential clinical intervention to assure patient safety” and should have been submitted to the agency for pre-market authorization.
Big MedDev has fired back, stating that that the software device functions of the system are non-device clinical decision support functions or non-device medical device data systems.
Heck of a try, but Big MedDev ain’t gonna win this one.
The FDA issued the guidance below last year and is really ramping up their oversight of medical device data systems and software, and it sure looks as though they are using this recall to send a message to industry about device software submissions.
Best pay attention, because you don’t want to end up on the receiving end of an FDA warning letter.
Especially if you have a device that is similarly managed by software and you think you can avoid submitting a PMA. Spoiler alert: you can’t.
Read the original article here: https://www.mddionline.com/digital-health/fda-warning-letter-to-j-j-s-abiomed-has-broad-implications-for-medtech
At the end of the day, regulatory strategy only works if it survives contact with real-world execution.
If you’re looking to sanity-check where you are:
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Video: What No One Tells You About Going to Market | Commercialization Pitfalls in MedTech
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Video: Apple Got Clearance. WHOOP Got a Warning Letter. Here’s What That Signals
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Substack: 791 FDA 483s. Only 54 Warning Letters. Here’s What That Really Means.
None of this is complicated—but it does require consistency, which is usually where things get interesting.
