FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC SUBMISSION TEMPLATE FOR INVESTIGATIONAL DEVICE EXEMPTION (IDE) APPLICATIONS; DRAFT GUIDANCE FOR SPONSORS AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Oct. 28 -- Food and Drug Administration has issued a notice called: Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Oct. 28 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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and C...