Today, FDA’s Center for Devices and Radiological Health published a proposed rule that would require manufacturers to electronically submit the device label and package insert for Class II and Class III devices labeled for “home-use.” The proposed rule is intended to implement the listing requirement for the submission of labels and package inserts for home-use medical devices under section 510(j) and 701(a) of the Food Drug and Cosmetic Act. For purposes of the proposed rule, a “home-use device” is any medical device that is labeled for use outside a professional health care facility.
The home-use device labeling submission requirements would only apply to Class II and III devices. The submissions would be accepted in PDF format, and waivers may be granted to submit labels and package inserts in other formats. Although the proposed rule does not apply to Class I devices, it would allow manufacturers to voluntarily submit device labels for any Class I home use device.
Data obtained by FDA, including a survey of adverse event reports, indicates that home-use devices have a higher risk of misuse due to lost or misplaced labeling/operating instructions. Patients and caregivers, as opposed to medical professionals, rely more on home-use device labeling and instructions and often, sometimes over a period of years, the labeling may become separated from the device.
Accordingly, FDA’s proposal is made with the ultimate goal of making the device labeling available to the public through a internet accessible FDA-managed database. The database will ensure that all users have quick and easy access to necessary labeling information, including benefit-risk information and instructions for use.
Comments on the proposed rule may be submitted beginning today. The comment period will be open for 90 days following its release (until January 17, 2017).