article thumbnail

Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device.

Medical 23
article thumbnail

This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

FDA Law

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S.