While medical device manufacturers must adhere to the Food and Drug Administration's (FDA) label compliance regulations, other stakeholders in the process often see just as big of an impact when these rules are changed. Namely, physicians, healthcare providers and even patients.
Now, the FDA says it wants those stakeholders to share their opinions on how effective the FDA's medical device label compliance is. Specifically, the FDA wants healthcare providers to rate current labeling based on its usefulness (particularly when it pertains to device instructions), coherence, organization and how often they are actually able to follow the instructions printed on the label.
The FDA has opened a 60-day comment period for healthcare providers and the general public, according to a Nov. 1 posting in the Federal Register.
"This work will allow FDA to assess whether HCPs find the format and content of device labeling clear, understandable, useful, and user-friendly. Findings will provide evidence to inform FDA's regulatory approach to standardizing medical device labeling across the United States," said the post.
It's fair to say the tone of those comments may affect how medical device manufacturers approach label compliance in the near future. Already, these companies must keep one eye open for any news regarding the FDA's unique device identification (UDI) systems, regulation which essentially seeks to standardize medical device labeling for improved label tracking and traceability.
Public comments may also help shape the face of medical device use in pediatric care. The FDA announced that same day that it will offer a workshop, "Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue," at its White Oaks campus in Silver Springs, Maryland.
It's all part of the FDA's efforts to review its own processes for analyzing the safety and effectiveness of medical devices. Manufacturers can prepare for the likely inevitable regulatory changes stemming from these discussions by taking a look at their internal labeling solutions and software.