FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC SUBMISSION TEMPLATE FOR MEDICAL DEVICE Q-SUBMISSIONS; DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, May 29 -- Food and Drug Administration has issued a notice called: Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on May 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Q-Submissions." FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health ...