Monday 9 January 2023
By Mitch on Monday 9 January 2023, 15:31 - Regulations
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 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The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.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 There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.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 The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version.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 5 February 2021
By Mitch on Friday 5 February 2021, 12:40 - Regulations
A Notice was published in the Federal Register the 15th January 2021, about the exemption of a long list of medical devices from premarket notification. This list, found in table 6 of the Notice, contains 83 class II devices.
Yet, we have to wait for 120 days, to see this Notice published with the list in its final version.
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.
Thursday 24 January 2019
By Mitch on Thursday 24 January 2019, 12:50 - Regulations
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.
Friday 10 February 2017
By Mitch on Friday 10 February 2017, 14:20 - Regulations
By Mitch on Friday 10 February 2017, 14:19 - Regulations
Friday 19 August 2016
By Mitch on Friday 19 August 2016, 13:48 - Regulations
The FDA released three new FDA guidances in July 2016:
- Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,
- The final guidance on General Wellness: Policy for Low Risk Devices.
Friday 5 February 2016
By Mitch on Friday 5 February 2016, 13:45 - Regulations
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 15 January 2016
By Mitch on Friday 15 January 2016, 14:30 - Standards
IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.
Friday 18 December 2015
By Mitch on Friday 18 December 2015, 15:33 - Misc
The IMDRF published in October 2015 the guidance document titled "Software as a Medical Device (SaMD): Application of Quality Management System" in its final version.
Wednesday 23 September 2015
By Mitch on Wednesday 23 September 2015, 09:57 - Standards
Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.
Friday 28 August 2015
By Mitch on Friday 28 August 2015, 12:54 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.
Friday 24 July 2015
By Mitch on Friday 24 July 2015, 11:57 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.
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.
Friday 21 November 2014
By Mitch on Friday 21 November 2014, 12:46 - Regulations
At last! The FDA has published last October a guidance about cybersecurity that matters!
Not that the guidance previously published about Off-the-shelf software cybersecurity wasn’t worth reading it (Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software), but its scope was more than reduced.