FDA Needs Suggestions for Pre-Submission Program

Want some feedback and advice from the staff at the U.S. Food and Drug Administration (FDA) before submitting your product for approval or clearance? If so, the agency wants your feedback on the best way to offer that advice.

Companies trying to develop and bring new medical devices to the market have complained about unclear and inconsistent application of agency rules after submitting proposals as well as confusing procedures when meeting with review staff.

Pre-Sub Program

In an effort to foster innovation, the agency issued a Draft Guidance on July 12 for a new program called, the Pre-Submission or “Pre-Sub” program to give companies a chance to ask questions and help medical device developers to identify regulatory requirements early in the device development process. The new program is an extension and name change of the existing pre-IDE (Investigational Device Exemption) program.

The agency says the main purpose of the new program remains the same as the pre-IDE program: “To facilitate providing advice to applicants when they have specific questions during product development and early protocol planning, about device studies that present significant risk(s) (SR) as well as non-significant risk(s) (NSR) or when developing protocols for clinical studies conducted outside of the United States to support future U.S. marketing applications.”

The guidance also describes the procedures that the agency intends to follow when industry representatives or application sponsors request a meeting with review staff.

The program will operate within the FDA’s existing medical device premarket regulatory pathways: IDE, PMA (Premarket Approval), HDE (Humanitarian Device Exemption), 510(k) (Premarket Notification) and de novo.

Avoiding Regulatory Hurdles

Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH), said, “No matter the regulatory pathway, FDA’s early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process.”

The guidance will advise device makers how to improve the effectiveness of their pre-market submissions by:

• Describing when device developers might benefit from early FDA feedback;

• Describing pre-submissions package content necessary for optimal FDA feedback: and

• Explaining how to best engage FDA in informal meetings to discuss the most efficient path with a new technology or planned regulatory submission

Instruction for Comments

You’ve got until October 11, 2012 to submit either electronic or written comments. Send electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number FDA-2012-D-0530.

To read the entire draft, click here.