The U.S. Food and Drug Administration (FDA) has issued a draft guidance that would give faster feedback to medical device manufacturers and researchers before they submit regulatory applications.
This draft guidance expands upon the FDA's existing Pre-Investigational Device Exemption (pre-IDE) program, which allows companies to obtain feedback during the investigational stage of a product and prior to a formal regulatory application. It is intended to foster innovation by helping medical device developers identify the regulatory requirements early in the development process of a device.
The new program, to be referred to as the Presubmission program, will operate within the FDA's existing medical device premarket regulatory programs. It is part of an ongoing commitment to facilitate earlier, more transparent, and more predictable interactions between the agency and innovators during the earliest stages of product development, according to the FDA.
The FDA intends for the guidance to advise device makers on how to improve the effectiveness of their premarket submissions by describing when device developers might benefit from early agency feedback. It also will describe presubmission package content necessary for optimal FDA feedback, and explain how to engage agency staff in informal meetings.
Public comment on the proposed guidance is requested through October 11. Instructions for submitting comments have been published in the July 12 issue of the Federal Register.
