alt Hacker Newsthey didn't appear to do that either though - they just uncritically report that it is an FDA rule preventing this company from doing repairs.
they didn't appear to do that either though - they just uncritically report that it is an FDA rule preventing this company from doing repairs.
Speaking from experience these types of technical details often get cut from news reporting anyways. I wouldn't be surprised if the author of this peice did in fact look that up but it got cut from the final copy.
I think this is likely the relevant regulations: https://24x7mag.com/standards/servicing-legislation/how-the-...
" the FDA believes the following types of activities, in general, involve changes that affect the legally marketed device’s performance or safety specifications and are likely to constitute remanufacturing:
. . .
If the company was no longer maintaining OEM parts for the older model device it might be prevented from using slightly different parts from newer models to repair the older model without basically needing to have the older device + new part be cleared as a completely different medical device. I'm speculating and this might not be entirely accurate.Edit: actually it appears that the company marketing this device did not comply with an FDA order to conduct a postmarket surveilence study to asses its risks.
In September 2015 the "FDA informed ReWalk that its noncompliance with the postmarket surveillance study deadline rendered the device misbranded." This is from a 2020 class action lawsuit against the company which was dismissed but it's not clear to me that the misbranding issue was ever taken care of, which could be the reason the company was initially hesitant to provide service to the device? This is not entirely clear to me one way or the other. https://casetext.com/case/yan-v-rewalk-robotics-ltd-3