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Friday, 7 February 2025
By Mitch on Friday, 7 February 2025, 13:53 - Regulations
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 - Regulations
And this is the Australian TGA who demonstrates that.
Friday, 29 March 2024
By Mitch on Friday, 29 March 2024, 13:42 - Regulations
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, 6 October 2023
By Mitch on Friday, 6 October 2023, 14:09 - Regulations
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, 10 June 2022
By Mitch on Friday, 10 June 2022, 13:47 - Regulations
The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.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 There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.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, 6 December 2021
By Mitch on Monday, 6 December 2021, 13:32 - Regulations
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 The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version.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.
Friday, 4 September 2020
By Mitch on Friday, 4 September 2020, 14:34 - Regulations
The FDA published in July the final version of the Guidance on Multiple Function Device Products. Despite the absence of the word "software" in the title, it addresses at first software medical devices. It also addresses hardware devices, but we will focus on software in this post.
Sunday, 3 May 2020
By Mitch on Sunday, 3 May 2020, 14:20 - Regulations
So we have a new guidance on cybersecurity for medical devices: the MDCG 2019-16. This is not the one we expected so quickly, but we're not going to complain about the existence of this guidance! It was published in December 2019. At last I found time to write a review.
This guidance covers a broad range of topics applicable to all stakeholders in the medical device supply chains, and to end-users. It explains a bit why it is 46 pages long.
Thursday, 24 January 2019
By Mitch on Thursday, 24 January 2019, 12:50 - Regulations
The US FDA published in October 2018 a new draft version of its guidance on the content of premarket submissions for management of cybersecurity in medical devices. Two months later, Health Canada published in December 2018 a draft guidance document on pre-market requirements for medical device cybersecurity.
Friday, 19 January 2018
By Mitch on Friday, 19 January 2018, 14:15 - Regulations
Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.
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.
Tuesday, 16 May 2017
By Mitch on Tuesday, 16 May 2017, 21:53 - Standards
After a long pause, we continue this series about cybersecurity in medical devices with a discussion on AAMI TIR57:2016 Principles for medical device security — Risk management.
Friday, 10 February 2017
By Mitch on Friday, 10 February 2017, 14:20 - Regulations
This article is a follow-up of the previous article on the Draft guidance on Postmarket Management of Cybersecurity in Medical Devices.
By Mitch on Friday, 10 February 2017, 14:19 - Regulations
This article is a follow-up of the article on the Draft guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.
Friday, 4 November 2016
By Mitch on Friday, 4 November 2016, 15:37 - Misc
The FDA released a guidance on clinical evaluation of standalone software medical device (a.k.a SAMD) in October 2016. This guidance is the same text and has the same presentation as the International Medical Device Regulatory Forum (IMDRF) guidance on SAMD clinical evaluation published in August 2016.
Friday, 19 August 2016
By Mitch on Friday, 19 August 2016, 13:48 - Regulations
The FDA released three new FDA guidances in July 2016:
Wednesday, 10 August 2016
By Mitch on Wednesday, 10 August 2016, 10:09 - Regulations
A new version of the MEDDEV 2.1/6 was published in July 2016.
The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.
Add to that a few typos, and you have the new version of the MEDDEV:
MEDDEV for nothing ♫ and tips for free ♬.
Friday, 5 February 2016
By Mitch on Friday, 5 February 2016, 13:45 - Regulations
The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.
Friday, 29 January 2016
By Mitch on Friday, 29 January 2016, 14:30 - Regulations
The FDA released one week ago a new draft guidance on Postmarket Management of Cybersecurity in Medical Devices.
This guidance is the sister of the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices released in 2014. Both guidances address cybersecurity at different steps of software lifecycle: the 2014 guidance is about cybersecurity during design and development, the 2016 draft guidance is about cybersecurity during post-market surveillance.
Friday, 20 March 2015
By Mitch on Friday, 20 March 2015, 17:03 - Regulations
If you watch from time to time the new guidances released by the FDA, you probably noticed that two guidances about software were released in january and february 2015.
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