Software in Medical Devices, by MD101 Consulting

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!

To continue the topic about FDA draft guidances related to software and information systems, the FDA put in its top list the release of the Guidance of Mobile Medical Apps.

Guidance of Mobile Medical Apps is in the "A-list" of FDA and should be released by the end of 2013.

In hot topics, we have also a warning letter sent by the FDA to Biosense Technologies. The mobile App named uChek Urine Analyzer and developed by Biosense Technologies, falls into the category of medical devices, says FDA. Biosense claims on its website that the App turns the smartphone into a medical lab.

With such claim, it's not surprising that the FDA wants Biosense to submit a 510k!

This is the second part of our discussion about Unique Device Identification (UDI).

Interrupting our series about IEC 62304 SOUP, we have breaking news from the FDA!
The FDA published this month a new Draft Guidance about Cyber Security and released a Safety Communication about Cybersecurity for Medical Devices and HospitalNetworks .

The federal agency recommends that manufacturers review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices. In other words, hacking treats, network intrusions, and the like, have to be addresses in the software risk assessment report.

Bouncing back to our series about SOUP, such risks shall be assessed when a SOUP is integrated in your software.

The AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software enters in the list of recognized standards by the FDA. See here on Federal Register website.

The Global Harmonization Task Force released an update of their guidance on Essential Principles of Safety and Performance of Medical Devices. It supersedes the last version released in 2005.

The proposal of new regulation for CE Mark of medical devices was unveiled last week. If you've not heard about it, you were in the desert without access to the internet.

I won't argue on the length of the document or the consequences of this possible new regulation on the early release of technologic improvements in the european market. I invite you to have a look at Mat's article.

What's new for software?

Let's see what's new for software in this proposal. To do so, I took my best PDF viewer and searched for "software" in the actual directive and in the new proposal.

Too many documents in too many places, that’s what I felt the first time I looked for guidances and other similar stuff about software medical devices.
Where do I find relevant documents?
Which one do I begin with?
My answer:
I created a page where I gather my own list of guidances. It’s a selection of guidances and recommendations for CE mark.

Click here to see the list.

Hope you enjoy it :-)

LESSIS, the federation of french editors of medical and social IT systems, proposes the creation of a unique agency to homologate health IT systems. Original article here (in french).

No more than 6 french governmental agencies are in charge of the homologation of health IT systems in France. Following the example of the CE mark, LESSIS proposes to build a common route to certification. Like the Afssaps for medical devices, a unique agency would be in charge of delivering the certificates, auditing the companies and applying sanctions.