Medical device manufacturers take heed: An important deadline is fast approaching. In 2013, the FDA finalized a unique device identification (UDI) system designed to make the tracking of medical devices more efficient. The FDA issued several compliance dates for meeting UDI requirements, the next of which is September 24, 2016. This date applies to class II devices and stand-alone software. Is your business ready?
Implementing UDI involves challenges in all aspects of a business’s operations, but medical device manufacturers and the healthcare industry in general should reap many long-term benefits from prompt compliance. Those benefits include improved inventory control, more accurate medical billing, a reduction in fraud, and ultimately, an increase in profits — not to mention improved quality and safety in healthcare for patients. And noncompliance or delayed compliance is not an option, or at least not a pleasant one. Failure to comply may result in serious legal consequences.
To make sure they understand the process and meet all deadlines, device manufacturers should start planning for UDI as soon as possible. This guide helps manufacturers prepare by:
- Tracing the history of UDI
- Explaining the requirements that manufacturers need to meet
- Describing the benefits of compliance (and the consequences of noncompliance)