Recently (14th September, 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple guidance Associated with Weight Loss and Fostering Medical Device Improvement.
In this draft guidance document, FDA recommends clinical study designs for devices with weight loss indications, and discusses how FDA considers benefit-risk analysis to support the indication. The devices come in a wide variety of designs, which can lead to a wide range of demonstrated weight loss and risks. The recommendations reflect current review practices of premarket submissions of these devices and aim to facilitate consistency and efficient review.
This draft guidance document provides FDA recommendations for non-clinical testing to support premarket submissions for medical devices with weight loss indications (such as premarket approvals (PMAs), investigational device exemption applications (IDEs), premarket notifications (510(k)s), and denovo classification requests).
There are several indications associated with weight loss, such as weight loss, weight reduction, weight management, and obesity treatment. This guidance reflects current premarket submission practices for these devices, and the recommendations are meant to facilitate efficient and consistent premarket submission reviews.
The Voluntary Improvement Program (VIP) is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices.
The VIP final guidance builds upon the framework piloted through FDA's Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program), which incorporated some of the pilot's best practices and lessons learned.
Currently, this voluntary program only applies to medical device manufacturers regulated by CDRH who are reviewing marketing applications under applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (including section 510(k), 513, 515, and 520).