FDA NEWS RELEASE
For Immediate Release: July 12, 2012
FDA outlines plans to provide earlier feedback on device product submissions
The U.S. Food and Drug Administration today issued a draft guidance that outlines the agency’s recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting a product- or research-specific application.
The draft guidance expands on the agency’s existing pre-Investigational Device Exemption (pre-IDE) program, which allows companies to obtain feedback on a product during the investigational stage and prior to the formal application process.
The new program will be referred to as the Pre-Submission or “Pre-Sub” program. It will operate within the FDA’s existing medical device premarket regulatory pathways: IDE, Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Premarket Notification (510(k)), and de novo. It is intended to foster innovation by helping medical device developers identify the regulatory requirements early in the device development process.
“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,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH).
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
“FDA feedback to device developers early in the process can ultimately lead to more timely regulatory actions and innovative new devices for patients,” said Alberto Gutierrez, Ph.D., director of CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety.
The Pre-Sub program is part of the FDA’s ongoing commitment to facilitate earlier, more transparent, and more predictable interactions between the agency and innovators during the earliest stages of product development.
The draft guidance is a commitment under the Medical Devices User Fee Amendments of 2012 (also referred to as MDUFA III) among the action items listed in FDA’s 2011 “Plan of Action for Implementation of 510(k) and Science Recommendations,” which is intended to enhance the predictability and transparency of CDRH’s regulatory pathways and to strengthen the 510(k) program.
The FDA is seeking public comment on the draft guidance. Instructions for submitting a comment are available in a Federal Register notice published today.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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