The FDA has recently released a draft guidance titled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” that will update and expand the pre-IDE program established in 1995 and the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.

Institutional Review Boards (IRBs), sometimes called Ethic Committees, are responsible for reviewing and approving research studies involving human subjects. The rules that govern IRBs are clearly laid out in 21 CFR 56 which contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA. The IRB has the authority to: