If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation. Recent announcements suggest that PTC is...
Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...
