Chris Vincent and I recently attended an AAMI training course held in Dublin on Human Factors for Medical devices. EU manufacturers and consultancies all attended with the hope of having some questions answered by the FDA.
The course was led by Robert North and Ed Israelski who did a great job in answering questions and giving their view points on what the FDA (CDER – combination products and CDRH – devices) look for in premarket submissions.
Hot topics included validation testing requirements, legacy devices, harmonisation of standards, IFU testing, use error risk analysis and post-market surveillance.
A wealth of interesting information surfaced throughout the 3 day course, such as the prospect of the FDA DRAFT guidance being taken out of DRAFT by the end of this year and that IEC62366-1 is expected to be harmonised in 2016.
It also became clearer that the FDA are interested in seeing evidence that manufacturers have explored post market data (using search engines such as MAUDE, MDR and Medsun) to gather feedback on existing devices at the start of a project. If a manufacturer does not include this data and consider known issues with devices currently in the market, then this can cause serious issues for manufacturers when it comes to applying for premarket submissions.
We asked a series of questions related to legacy products and what this means for manufacturers and it appears that if a manufacturer wants to make a change to a device then the FDA will want to see evidence that the manufacturer has:
- Identified their intended users and their user characteristics, defined the environments of use for their device and established all use scenarios. The FDA would like all of this information pulled out from existing documentation and collated into 1 document called a Use Specification as defined in IEC62366-1.
- Carried out the appropriate use error risk analysis, in the form of a uFMEA or an equivalent risk management document.
- Addressed some of the known issues with the product that have been identified post market release.
From conversations with the FDA it was suggested that their view on this is that manufacturers should already have all of this information available and that all manufacturers would need to do is to pull out the relevant information into the appropriate documentation.
It is further viewed that if the outcome of the manufacturer’s use error risk analysis deems that the change a manufacturer is making will not in any way jeopardise the safe and effective use of the device, or that any new risks that are introduced as a result of the change are acceptable, then the manufacturer does not have to go any further. However, if it is found that the risk is not acceptable, then and only then will the manufacturer have to go through the usability engineering process which would involve doing usability testing.
This resolved some ambiguity had by individuals in the room but also sparked off a whole new set of questions for others. After asking these questions, AAMI have now announced a new course which aims to focus on providing more clarity surrounding legacy devices and advanced topics for individuals who require more in-depth information surrounding FDA requirements.
Ed and Robert were surprised to see how advanced Europe has become in their knowledge of Human Factors and it would not surprise me if, moving forwards, the HF standards and guidance documents incorporate some of the feedback the FDA received during training course!
Posted by PDD
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