FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC SUBMISSION TEMPLATE FOR MEDICAL DEVICE PREMARKET APPROVAL APPLICATIONS (PMAS); DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Sept. 18 -- Food and Drug Administration has issued a notice called: Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Sept. 18 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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Cen...