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Friday, 7 February 2025
By Mitch on Friday, 7 February 2025, 13:53
The FDA published early January 2025, a long-awaited guidance about Artificial Intelligence Enabled device software functions. This guidance contains FDA's recommendations on how to document an AI-enabled device in marketing submissions.
Almost 70 pages long, this guidance is a monster!
Friday, 26 July 2024
By Mitch on Friday, 26 July 2024, 13:12
And this is the Australian TGA who demonstrates that.
Friday, 19 April 2024
By Mitch on Friday, 19 April 2024, 13:32
Yes, 2025.
Why? Because Windows 10 end-of-support is the 5th October 2025.
Are there any MDD SaMD running on Windows 11? No, Windows 11 was released the 5th October 2021, just after May 2021.
So, all MDD SaMD are officially running on Windows 10. Till the 5th October 2025.
Thank-you Microsoft, you set a regulatory deadline involuntarily!
Friday, 29 March 2024
By Mitch on Friday, 29 March 2024, 13:42
The IMDFR organization published in January 2024 a new document on Medical Device Software: Considerations for Device and Risk Characterization
Say briefly, this document is a gem!
Friday, 20 October 2023
By Mitch on Friday, 20 October 2023, 14:12
The FDA released in August 2023 a new version of their guidance on off-the-shelf software (OTSS) use in medical devices. It’s worth noting that this guidance didn’t go through a draft version.
Something visible in the content of that guidance.
Friday, 6 October 2023
By Mitch on Friday, 6 October 2023, 14:09
The final version of the FDA guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions was published the 27th September 2023.
Friday, 16 June 2023
By Mitch on Friday, 16 June 2023, 13:54
The final version of the FDA guidance on Content of Premarket Submissions for Device Software Functions has been published.
Monday, 9 January 2023
By Mitch on Monday, 9 January 2023, 15:31
The FDA added late December 2022 IEC 81001-5-1 to the list of recognized consensus standards.
That's it. After beating around the bush on this blog on whether UL 2900-x or IEC 81001-5-1 would be applicable to 510(k) submissions and other regulatory clearances, we now have the answer.
We can use IEC 81001-5-1 as:
A good way to make thing (a bit) more simple.
Remark: UL 2900-x can still be applied in the US!
Friday, 6 January 2023
By Mitch on Friday, 6 January 2023, 13:24
The latest version of the FDA Guidance on Clinical Decision Support Software (CDSS) was published in September 2022. Here is a review of the document and a short comparison with the status of CDS with regard to the MDR.
Friday, 16 December 2022
By Mitch on Friday, 16 December 2022, 13:50
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.
Friday, 30 September 2022
By Mitch on Friday, 30 September 2022, 14:01
That’s the story of the pig and the hen for breakfast: the pig is involved (ham) and the hen is concerned (eggs). With the NIS2 directive in preparation, a medical device manufacturer will be in either situation.
Friday, 2 September 2022
By Mitch on Friday, 2 September 2022, 12:47
The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.
Monday, 27 June 2022
By Mitch on Monday, 27 June 2022, 14:50
The UK Government response to consultation on the future regulation of medical devices in the United Kingdom has been published on Sunday 26th June 2022.
Friday, 10 June 2022
By Mitch on Friday, 10 June 2022, 13:47
The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance will supersede the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices of 2014, when it is finalized. There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.
Monday, 23 May 2022
By Mitch on Monday, 23 May 2022, 13:08
The Medical Device Regulation (MDR) is born bad. The success of a project depends on its timing. It is clear that the MDR has been plagued by a series of setbacks that have hindered its implementation.
Friday, 13 May 2022
By Mitch on Friday, 13 May 2022, 13:55
Post-Market Surveillance (PMS) is one of the strengthened requirements of the Medical Device Regulation (MDR). Performing an effective PMS can be a time consuming task, shared by several departments of MD manufacturers. This is also true for SaMD.
Friday, 15 April 2022
By Mitch on Friday, 15 April 2022, 14:26
We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.
Friday, 25 February 2022
By Mitch on Friday, 25 February 2022, 14:28
Medical device regulations require the manufacturers to define lifetime for their devices. In the case of SaMD, this requirement needs some interpretation.
Monday, 6 December 2021
By Mitch on Monday, 6 December 2021, 13:32
Great news! The FDA announced their list of new or revised guidances for 2022. Software is going to be privileged, with 6 guidances on Clinical Decision Support software, SaMD risk categorization, cybersecurity, QMS SW, and Artificial Intelligence / Machine Learning. The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version. This little change in the title is a sign of the times.
Monday, 8 November 2021
By Mitch on Monday, 8 November 2021, 13:56
That is the question.
MD manufacturers are pressed by end-users to implement changes. Especially SaMD, where the users are used to receiving new versions weekly or monthly. Thus, Class I MDD SaMD manufacturers are pressed to find a way to qualify their software changes as non-substantial according to the MDCG 2020-3. Otherwise, they can't deliver new versions to their end-users, blocked by the deadly MDR rule 11 and its class IIa trap.
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