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Latest From Ferdous Al-Faruque
As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.
There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them
The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.
After discovering a correlation between certain chemically coated devices and serious adverse events, the agency has issued a couple of final guidance documents, including a labeling guidance to increase public awareness of the risks. The coating is meant to help physicians more easily slide devices – such as catheters and guidewires – into patients, but in some cases they’ve been associated with obstruction of blood vessels, stroke and death.
The US agency issued a safety communication on 1 October warning manufacturers, providers and patients of 11 serious exploits on a wide range of connected medical devices that could allow malicious hackers to not just steal patient data, but harm patients by altering how the devices function.
Noting the latest round of user-fee negotiations are coming up, FDA device center head Jeff Shuren recently floated the idea of developing statutory building blocks – or what he calls ‘regulatory Legos’ – that would allow the agency to keep up with rapidly advancing medtech products. Instead of constantly asking Congress for new statutory authorities as technology advances, he said, the FDA could have broader authority to bring new products not covered under its current authority to market.
The US FDA has been furiously releasing a boatload of updated, draft and new guidance documents over the past month. On this week’s podcast, we discuss three of them, related to clinical decision support (CDS) software, Humanitarian Use Devices (HUD) and Humanitarian Device Exemption (HDE).