Our Blog

FDA considers possibility of standardizing medical device labels

Sometimes an inherently dangerous product is perfectly safe if used as directed. There could be a variety of sources of information about using a product safely, but one of the most common is product packaging and labeling.

For example, picture a sleep aid medication. Take too much, and it could be harmful. But labels on the packaging tell consumers how much to take and when to take it in order to avoid harmful side effects. Consumers know they will find this information on the packaging when they purchase a sleep aid, and they know how to quickly find it because they have had to do so hundreds of times before for similar products.

Under U.S. Food and Drug Administration regulations, all food and pharmaceutical products must adhere to a series of strict labeling requirements. These FDA regulations cover everything from the font size and layout of labels to required information and mandatory statements. However, there are currently no FDA standardized labeling requirements for medical devices.

In a Federal Register posting from September 12, the FDA announced that it plans to launch a new study of medical device labeling. Labeling from six types of medical devices will be compared against two separate “standard content and format” labels that FDA researchers have developed. A number of healthcare provider respondents will have a say in how effective they feel each of the labels are.

Will the FDA soon standardize medical device labels? It is likely, given the attention the agency has been paying to the issue lately. What remains to be seen is whether there will be one standard format for labeling medical devices or several depending on intended use, and whether such labeling requirements will actually improve patient care.

 

Source: Regulatory Affairs Professionals Society, “FDA to Test out New Standardized Medical Device Labels in Proposed Study,” Alexander Gaffney, Sept. 15, 2014