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Friday, 12 January 2018
By Mitch on Friday, 12 January 2018, 15:00 - Regulations
Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.
Friday, 14 February 2014
By Mitch on Friday, 14 February 2014, 12:48 - Misc
To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.
Friday, 17 January 2014
By Mitch on Friday, 17 January 2014, 12:36 - Regulations
In the last article, we saw the concerns about the reliability of wireless connections and how to handle them.
Today, we are going to have a look at something quite important for mobile platforms: usability and humans factors engineering (HFE).
Wednesday, 25 September 2013
By Mitch on Wednesday, 25 September 2013, 17:28 - Regulations
After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!
Friday, 13 July 2012
By Mitch on Friday, 13 July 2012, 15:04 - Misc
Happtique, an appstore for mobile medical devices has drafted an
App Certification Program.
This not a program or a process but a list of functional and non functional
requirements that mobile health apps should respect to be certified - according
to Happtique. It' a bit like the requirements of Apple to be authorized to
place an app in the Apple Store. Happtique publishes your app on its store if
you are compliant with its certification program.
There is a lot of work behind this document, and a lot of knowledge. However I
don't think this is enough to make a certification program. This document
focuses on the results, whereas all software development standards focus on the
processes. FDA focuses also on the processes when its auditors verify
compliance to 21.CFR.
In the scale of precedence of documents, I would put it here:
It's obvious that Happtique wants to make some noise with its certification
program (and it has reached his goal, you're reading this post). But I have to
recognize that this document contains a big source of information for software
requirements. The content of this certification program is a perfect source of
ideas to write a software requirements specification (SRS).
The world of mHealth is moving fast. In the same kind of article, I have found
Tech
Barbarians at the Medtech Gates, this article is a good summary of
antagonist forces at stake. On the one hand, the regulators and their, so
called, ante-Flood rules. On the other hand, the software industry with its new
world of mHealth. Guess who's going to have the last word? If, like me, you
don't have the answer, continue to apply the standards and regulations...
Bye.
Friday, 6 April 2012
By Mitch on Friday, 6 April 2012, 11:08 - Misc
This article is the last of three articles which deal with the concept of
"inflation" of medical devices. The first
one was on inflation of standards, the second
about inflation of regulations. This one, the most interesting to my eyes, is
about multiplication of apps on mobile devices, especially smartphones and
tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical"
categories of the Apple or Android appstores. Many of these apps are classified
as medical devices and are in the scope of regulations like FDA and CE Mark.
Note that some apps may be regulated the FDA but not the CE Mark or
vice-versa.
Thursday, 5 January 2012
By Mitch on Thursday, 5 January 2012, 19:45 - Misc
Dozens of companies recall their medical devices every month. A recall
happens when something wrong happened with the device, like a bad labeling or a
bad sterilization. It's the responsibility of the manufacturer to warn ALL
their customers and the government agencies that a given lot or batch of
products has a defect. The batches shall be destroyed or sent back to the
manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone
app used to compute a score to assess the desease of patients according to
complex algorithms. There is a bug in the app and it gives wrong results.
Monday, 14 November 2011
By Mitch on Monday, 14 November 2011, 10:32 - Regulations
The boom of mobile apps on smart phones clearly impacts the medical devices industry. Doctors are eager to have the last software gadget (the app) on their hardware gadget (the smartphone, the tablet). As a result, many apps on Apple Store and Android Store fall into the scope of medical devices: terminal to remotely display medical images, apps to compute doses of medicines, an so on ... The list is long.
And gess what? These apps shall be certified before being put in the Apple-Android stores. The FDA is clear about these "mobile medical apps" in a draft guidance published in july 2011: "For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification." see the Draft Guidance. For the CE mark, the rule is the same, mobile medical apps fall into the category of active medical devices.
The big family of medical devices is getting more and more children. Welcome to the baby smartphone apps!
