Status of FDA Regulation and UDI Pros/Cons

by Brittany Sutton

The FDA is finalizing their proposed rule to require a Unique Device Identifier (UDI) for each medical device. Though this ruling has been pushed back several times, the decision should be ready by the UDI Conference led by the FDA this September. While companies wait for the final ruling, they weigh the costs and benefits of using UDIs.

Cons

Companies who don’t support UDIs cite cost of implementation as their main concern. A new system would have to be put in place to assign each device with a unique device identifier, and they need to ensure they are paired correctly. This will take time to get used to and may require the company to outsource to solve their problem more easily.

Pros

Despite these negatives, UDIs will offer companies many more positives. Companies will be able to keep track of every single item they produce. This will provide micro-targeted recalls and would therefore save money and protect consumers. Companies will be able to target specific items or lots for recalls instead of total recalls. This will help help brands stay strong by reducing the scale and therefore media coverage of recalls and by increasing consumer confidence in the safety of their products.

Tracking inventory at this level will also help companies manage their supply chain more efficiently. If an individual item needs to be located, it will be easily accessible with its UDI. Patients will receive their medical devices more quickly, and medical companies can connect with healthcare professionals using the devices instantly whenever necessary.

Companies that produce any Class III medical devices will have to act most urgently, as they will only have one year from the release date of the ruling to comply with the regulation.

Ross PPD is excited to offer low-cost, efficient solutions for UDIs. Find out more at rossppd.com/products/mddtrack.