CDRH Electronic Submission for Home Use Device Labeling

PILOT PROGRAM

FDA is accepting requests starting May 1st to May 31st 2015 for participation in their pilot program for electronic submission of home use device labeling. The labelling, including safety information and instructions for use, will be submitted through the registration and listing database. This database will be available to patients, caregivers, and the healthcare community, providing them with essential information about the device.

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.

? Email us at info@mdiconsultants.com if you have further questions. Ref: Home Use Labeling Pilot Program