Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

Description

This draft guidance document provides the FDA’s recommendations for the non-clinical testing to support premarket submissions (e.g., Premarket Approval (PMA) Applications,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.

Scope & Applicability

Regulatory Context

• 21CFR876.5981§ 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.

  (a) Identification. An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient uRead full regulation →

• 21CFR814.39§ 814.39 PMA supplements.

  (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →

• 21CFR876.5982§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.

  (a) Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.Read full regulation →

• 21CFR814.20§ 814.20 Application.

  (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR860.220§ 860.220 De Novo request content.

  (a) Unless the requester justifies an omission in accordance with paragraph (c) of this section, a De Novo request must include:Read full regulation →

• 21CFR801.109§ 801.109 Prescription devices.

  A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

• CGMP/QSR/Medical Devices/Adulterated

  Contec Medical Systems Co., Ltd.

  2025-10-28

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  CCIC Huatongwei International Inspection Co., Ltd.

  2025-08-26

• CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded

  Uscom Kft

  2025-08-26

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  Jiangsu Kerbio Medical Technology Group Co.

  2025-08-26

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Visgeneer, Inc

  2025-08-05

• CGMP/QSR/Medical Devices/Adulterated

  Onkos Surgical, Inc.

  2025-07-29

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  Next Science LLC

  2025-04-01

• CGMP/QSR/Medical Devices/Adulterated

  Dexcom, Inc.

  2025-03-25

• CGMP/QSR/Medical Devices/Adulterated

  Randox Laboratories Limited

  2025-01-14

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Xoran Technologies, LLC

  2025-01-14

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