Regulatory Terms Starting With T

Technology Transfer (Tech Transfer)

The documented process of moving manufacturing technology and knowledge from one site or party to another to enable production at the new location.

Therapeutic Goods Administration (TGA)

Australia's regulatory agency for therapeutic goods including prescription medicines, medical devices, and biologicals.

Traditional 510(k) (Traditional 510(k))

The standard 510(k) premarket notification pathway for Class II devices demonstrating substantial equivalence to a predicate.