Implant

Being an implant affects US classification and whether a study is a significant risk study. The EU uses the term 'implantable device' with different criteria, so the same product can be described differently in each market.

Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part.

21 CFR, 812.3

Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise to protect human health.

21 CFR, 860.3

Both definitions use 30 days. Part 812 counts placement of 30 days or more and lets FDA treat shorter placement as an implant for study purposes; part 860 requires continuous implantation for that period, unless the Commissioner decides otherwise.