Q: What’s in store for the medical device sector in 2014?
The Final Rule for FDA’s Unique Device Identification (UDI) mandate is now released and will be in focus in 2014. Class III device manufacturers will need to comply by September 2014, unless granted an exception (and excluding grandfathered salable inventory). The “go-live” obligations include: updating their quality system as appropriate; establishing a unique Device Identifier [DI] for each device; changes to package labeling for AIDC marking and standardized date formatting; and publishing information to FDA’s GUDID database.
Similar requirements apply to the other device classes in subsequent years. Device manufacturers and their contract manufacturing partners will be refining their internal programs and systems as they approach compliance dates.
One obvious challenge is the control of data and creation of GUDID records; a program generally referred to as Master Data Management. The GUDID database is an integral part of the UDI program and these data records require as much care and diligence as the pending label copy updates.
For a subset of manufacturers, direct part marking (DPM) represents another significant challenge. Some devices will require a physical UDI marking as soon as September 2015. Given the complexity of this challenge, impacted manufacturers will begin DPM research in earnest in 2014.