IEC 81001-5-1 was added to the list of recognized consensus standards
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 Secure Product Development Framework according to the latest draft FDA guidance on cybersecurity,
- A method of answer to GSPR on cybersecurity of EU MDR and IVDR.
A good way to make thing (a bit) more simple.
Remark: UL 2900-x can still be applied in the US!