Contact Support

The intricacies of FDA regulations

The Federal Drug Administration (FDA) provides regulation for food, drugs, medical devices, radiation-emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products.  Just in the radiation-emitting products category alone, they are responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. That is a lot of oversight! The intricacies of FDA regulations come down to the health and safety of consumers, so while it may seem overwhelming, it has proven to be a vital part of keeping consumers healthy and safe.

The same goes for the regulation of labels for these products. The process may not be as intricate, but the requirements are not optional. “Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device.” Some of the regulations affecting medical devices can be found under 21 CFR Part of the Code of Federal Regulations (CFR) and include:

  • General Device Labeling
  • The use of symbols on labels
  • Unique Device Identification (UDI)
  • Medical Device Reporting
  • Medical Device Tracking Requirements

If you are in the medical device industry and looking for a new labeling solution, finding one that specializes in medical device labeling is optimal.  These solutions will have compliance protocols in place and ensure your labels meet the requirements of this highly regulated industry.