The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH Electronic Submission for Home Use Device Labeling Pilot Program. FDA will accept requests for participation in the Electronic Submission for Home Use Device Labeling Pilot from May 1, 2015, through May 31, 2015. The pilot will proceed for six months, from July 1, 2015, through December 31, 2015. Participation in the pilot is open to applicants who label their device(s) for home use. Participants will be submitting their labeling through the registration and listing database which is a familiar system to all manufacturers who annually list their products with FDA.
Home use devices have significant public health importance to patients, caregivers, and healthcare professionals. Therefore, it is necessary to ensure that users are able to access necessary information for use, including safety information and instructions for use. This database would house labeling for home use devices and fill an important gap in the information available to patients, caregivers, and the healthcare community concerning home use devices. Comments received during the CDRH Home Use Device Labeling Pilot will be used to evaluate the usability of the electronic submissions database.
Volunteers interested in participating in the pilot should contact Mary Weick-Brady by email at Mary.Brady@fda.hhs.gov. The following information should be included in the request: Contact name, contact phone number, and contact email address. FDA will contact interested applicants to discuss the Pilot Program.
The Federal Register (FR) Notice provides additional information about the Electronic Submission for Home Use Device Labeling Pilot Program.
If you have questions about this Pilot Program, please contact: Mary Weick-Brady, Center for Devices and Radiological Health, Food and Drug Administration via email or phone (301) 796-6089.