The FDA has recently released a draft guidance titled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” that will update and expand the pre-IDE program established in 1995 and the associated Blue Book Memo from 1999. The program will be renamed the Pre-Submission, or Pre-Sub, program, and will be broadened to include other device submissions, including PMA applications, HDE applications, and 510(k) Submissions.