The study will look into whether a standard format of labeling would be beneficial to healthcare providers, as the regulator worries current labeling is too complicated and difficult to navigate.
While medical device makers are required to label their products with certain information, they have a lot more flexibility when it comes to the format and layout of that information, as pointed out by RAPS. These format and layout inconsistencies make it challenging to gather and compare medical device labeling information, resulting in the absence of a single repository for labels.
The study, announced in a Federal Register notice, is the third part of a three-part study. The FDA conducted focus groups of healthcare practitioners, asking them what they want in labeling, where they find labeling, what the most important sections of labeling are and whether they even look at labeling. Responses indicated health care professionals don’t look at labeling because it’s complicated and they typically can’t find the information they seek in one section. The practitioners said they would like an abbreviated version of labeling — so they could find information more easily — and a standard content of labeling. The focus group respondents also indicated they would like to find the information electronically and in one place.
Based on the previous phases of the study, the FDA is looking to test a standard content of labeling against an existing piece of the same labeling to determine whether health care practitioners can find what they need in a more consistent and easy way.
To achieve this, the FDA’s study will compare existing device labeling from approximately six different types of medical devices with a standard content and format of the same labeling, which FDA researchers are crafting using existing labeling as their source of the information.
The regulator wants to assess the usability and usefulness of a draft standard content and format of device labeling to see whether health care practitioners find the format and content of device labeling clearer, more understandable, useful and user-friendly. Findings will inform the FDA’s planned regulatory approach to standardizing medical device labeling.
It’s worth noting that the FDA specified in a response to a comment that the study is “a cognitive testing of a standard content of labeling” and that the study doesn’t address standard of care-related questions. Seemingly alluding to off-label use, the regulator responded to a comment stating that the agency should question whether physicians are required by the standard of care to read user instructions by writing that it doesn’t “regulate the practice of medicine,” but rather “labeling that accompanies a device.”