I'm sorry, but this is just patently false. The FDA requires extensive V&V testing, especially for medical devices that have a significant chance to kill the people that it's used on. That, and you need to have a very sophisticated quality management system (QMS) in place that tracks all the changes you make during your design and test process, links up source requirements to passing test reports in an auditable way, tracks all of your manufacturing information (including which batches were tested using what procedures, and the results), all of which can be randomly audited at any time, no matter where the facility is located on the world.

You may be referring to the 510k (pre-existing predicate device) pathway, which has been abused by companies to leapfrog and skip _some_ of the more stringent test requirements, but they still need to prove similarities, and that requires real data. However, in the vast majority of cases, these devices are things like masks, IV tubing sets, etc, not complex life saving equipment, which gets an enormous amount of scrutiny. If anything, it's the medical device companies that are at fault for lobbying Congress to allow abuse of 510k pathways, and Congress for allowing these things to happen.

do you have experience in the discipline? It doesn’t sound like you do.

I have some experience, and i can think of about a half dozen ways cpap machines and hearing aids could cause serious harm as a result of design flaws or lack of QA that would be de rigeur if not for regulatory pressure.

there's an ongoing CPAP recall, so there's at least one way they can be dangerous

https://www.fda.gov/medical-devices/safety-communications/ce...