Software Freedom Law Centers claims that the FDA requirements for medical devices put most of the responsibility of quality assurance on the manufacturer. It does not seem like the FDA provides much of an assurance of quality. Note: this is not my field of expertise, there is good chance I am very wrong, just following a short paper trail of laws, there maybe more laws (or practices) that I am missing that may indicate different FDA regulation controls for medical devices.

https://www.softwarefreedom.org/resources/2010/transparent-m...

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFR...