You KNOW your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to reconsider. 🤨
The FDA recently published a list of 83 medical devices that they have suggested for down-classification.
Most devices on the list can be safely down-classified without issue.
But others on this list – namely ventilators and some digital health devices such as EKG software- have benefitted from close FDA scrutiny during the 510(k) submission process.
These devices are safe precisely because they have been so closely regulated, not because they are simple to use and present limited risk to the patient.
And while it can be argued that the manufacturers speaking up are trying to protect their R+D investments and market share, they are also likely concerned about the impact to patient safety.
Allowing some life-supporting medical devices to come to market with much less regulatory oversight – or none at all – presents a huge risk to the patients who rely on these devices to survive.
This video explains in greater detail the risks presented by this proposed deregulation of medical devices by the FDA: www.youtube.com/watch?v=u3FouBnCg1Y
And here’s an article describing how manufacturers are pushing back: https://www.medtechdive.com/news/baxter-digital-health-startups-lead-pushback-against-510k-exemptions/597159/?
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