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Though you’ll be able to touch upon any steering at any time (see 21 CFR 10.115(g)(5)), to make sure that the FDA considers your touch upon a draft steering earlier than it begins work on the ultimate model of the steering, submit both on-line or written feedback on the draft steering earlier than the shut date.
If unable to submit feedback on-line, please mail written feedback to:
Meals and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written feedback must be recognized with this doc’s docket quantity: FDA-2019-N-4060
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Guidance Issuing Office
Center for Devices and Radiological Health
This draft guidance document provides the FDA’s recommendations for the non-clinical testing to support premarket submissions (e.g., Premarket Approval (PMA) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests) for medical devices with indications for use associated with weight loss. Examples of indications associated with weight loss include indications for weight loss, weight reduction, weight management, or obesity treatment in patients who are overweight or have obesity. Due to the wide variety of device designs, among other things, there can be variability in the demonstrated weight loss and risk associated with these devices, as well as variability in the applicability of some of the recommended testing. The recommendations reflect current review practices of premarket submissions for these devices and are intended to promote consistency and facilitate efficient review of these submissions.