🔥 Find me at MedicalDevicesGroup.net 🔥
2 min reading time
As originally shared by Rana Arefieg.
In a blog post this week, Scott Gottlieb highlighted the Digital Health Innovation Plan that will clarify how the FDA regulates digital medical devices and apps.
Thanks, Ginger. I’ve been thinking that if these devices pose low enough risk to support market entry based on certification alone, they pose low enough risk that they would be Class I 510(k) exempt, which would potentially leave them at liberty to decide what certifications, if any, to pursue.
FDA already put out a guidance that, as I understand it, indicated FDA had no intention (not even via 510(k) exemption) to regulate non-invasive/non-implanted “general wellness” products, which I think would include a lot of the lower risk “digital health” products. Then Congress hastily passed the 21st Century Cures Act, excluding “digital” wellness products from the definition of a medical device, without reference to invasiveness or implant.
On the whole, it seems to me that this area may be suffering from too many cooks, not all of whom necessarily belong in a kitchen.
I don’t see how a certification program would be expected to support innovation. I would expect the cost of certification to stifle innovation, rather than promote it.
When the FDA “certifies” a new device, the cost of that “certification” is heavily subsidized with tax dollars. FDA “certifies” companies to be in compliance with the QSR for free, while a hefty fee must be paid for ISO 13485 certification. Many startups have been taken aback to discover that the fee a notified bodies would charge to certify its innovative new device are many times higher than FDA’s user fee for review of the same device.
Am I missing something here?
Important step. Better if it was 2 years ago
These devices, if stand-alone software and 510(k) exempt, would have more to do than now if they had to certify if something like IEC 62304 certification was required or expected.
But for typical hardware/software software devices, certification to IEC 60601-1, and EMC IEC 60601-1-2 and other standards is already expected. Just would not have the expense and timeline for FDA review, after you go through certification. But you better have that QSR compliant documentation in your files in the event of inspection!
A lot depends on the details of the certification and the parties that are going to be involved in making those determinations. If CE Marking is any indication, I think we need to look hard at the parties overseeing certification because there is much inconsistency between the different bodies and even within their own teams. Also, with the focus on digital health/SaMD I think these bodies would need to examine how they assess products because many of them still bring a hardware oriented view of things.
This certification program sounds very interesting! aycan has an FDA cleared mobile iPad app for viewing DICOM images.
Thanks Rana Arefieg for posting this. Scott Gottlieb is a blessing for the healthcare industry in the US. The digital capabilities available today and the ones in development are the base for reducing cost of healthcare and he gets that.
Most FDA initiatives seem to be driven by corruption & inefficiencies which lead to sub-standard healthcare.
Change and progress
Lot depends upon who is certifying and validating
David Lee Scher,MD, FACP, FACC, FHRS, FESC
I was proud to be part of Happtique which foresaw the need for such a certification program for mobile medical apps.
Good morning sir, please can I have further details
Marked as spam
Meet your next client here. Join our medical devices group community.
Please log in to post questions.