Saw this at @jhalamka. In February, the FDA released a rule regulating “Medical Device Data Systems”.
Dr. Halamka offers a useful primer on the MDDS concept. He quotes a vendor stating that they are preparing to register their intraoperation interfaces (e.g. RIS/EDR, LIS/EDR.) It sounds to me that any sort of portable devices for displaying medical data are covered by the MDDS definition. Software that claims to display medical data for physician use is also covered according to this mobihealthnews article.
Selling a class I device requires internal quality controls and adverse event tracking. I am curious what kind of adverse events will be filed for software products after this rule comes into effect.
Tags: fda · softwareNo Comments
0 responses so far ↓
There are no comments yet...Kick things off by filling out the form below.