The U.S. Food and Drug Administration (FDA) has released a draft guidance document titled “Medical Devices: Pre-Submission Program and Meetings with FDA Staff,” which was published in the July 13 issue of the Federal Register and is open for public comment.
The guidance document updates the pre-Investigational Device Exemption (IDE) program to reflect a broader scope, which now includes other device submission program areas such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, and Premarket Notification (510(k)) submissions, as well as addresses questions related to whether a clinical study requires an IDE submission. The guidance further broadens the scope of the program to include those devices regulated by the Center for Biologics Evaluation and Research. Due to its broadened scope, the name of the program is being changed from the pre-IDE program to the Pre-Submission (Pre-Sub) program.
According to the guidance, the main purpose of the Pre-Sub program remains the same: “to provide the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or marketing application. The Pre-Sub program can also provide a mechanism for the FDA to provide advice to applicants who are developing protocols for clinical studies for which an IDE would not be required, such as studies of non-significant risk devices or for clinical studies conducted outside of the U.S. to support future U.S. marketing applications. Consequently, the Pre-Sub program can provide an efficient path from device concept to market while facilitating the agency’s goal of fostering the development of new medical devices.”
Comments on the draft guidance should be submitted by October 11, 2012. When final, this document will supersede “Pre-IDE Program: Issues and Answers” - Blue Book Memo D99-1, dated March 25, 1999.
Comments on the draft guidance may be submitted electronically to www.regulations.gov. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should reference docket number FDA-2012-D-0530.