CDRH Industry: FDA issues Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a proposed rule for manufacturers to electronically submit labeling information for Class II and Class III devices labeled for home use. The proposed rule also allows manufacturers to voluntarily submit device labels for any Class I home use device.

Home use devices have significant public health importance to patients, caregivers, and health care professionals. Therefore, it is necessary to ensure that all users have quick and easy access to necessary labeling information, including benefit-risk information and instructions for use. The FDA plans to make this device labeling information publicly available through an FDA-managed or partner website to fill an important information gap concerning home use devices.

Comments on the proposed rule may be submitted to the public docket FDA-2016-N-2491beginning October 17, 2016.  The comment period will be open for 90 days following its release (until January 17, 2017).  To comment, go to regulations.gov, then copy and paste the docket number in the search field. After the comment period closes, the FDA will review all comments prior to issuing the final rule.

If you have general questions about this proposed rule, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.

Center for Devices and Radiological Health
Food and Drug Administration