Last October, FDA published a proposed rule regarding the electronic submission of labels and package inserts for home-use medical devices, which are defined as devices labeled for use outside a professional healthcare facility and include diabetic test strips, powered wheelchairs and OTC catheters. While this proposed rule is limited in scope… when considered with the recent advancements in FURLS technology, it provides an efficient mechanism for FDA to test-run a system for requiring all medical devices to provide electronic submissions of labeling and package inserts in the future.
The comment period for this proposed rule ended January 17, 2017. FDA typically reviews those comments and then issues a final rule. The regulations would take effect 90 days after publication of the final rule and would amend FDA’s current listing regulations to require the submission of electronic versions of the label and package inserts of Class II and III home-use medical devices when these devices are listed with FDA.
How Does it Work?
Establishments would use FURLS, FDA’s current establishment registration and listing platform, to upload labels and package inserts. When an establishment lists a device, it will also be required to upload a digital version of the device’s label and package insert. This is similar to the process used currently by tobacco product establishments. Submissions would take place during the annual registration and listing period from October 1st to December 31st of each year. FDA would then use the information to develop a publicly accessible database.
Although the proposed rule is limited to class II and III home-use medical devices, when viewed in light of FDA’s recent FURLS advances for label submissions of tobacco products, it is clear that FDA is rapidly advancing its technological capabilities to accommodate electronic label and package insert submissions for all medical devices.
Please contact us if you have any further inquiries relating to the future of medical device labeling.
