The draft guidance has been divided into two documents that will convey the FDA's current perspective on Medical Devices with Indications Associated with Weight Loss. The first document addresses considerations for clinical studies and risk-benefit assessments, while the second one focuses on non-clinical recommendations.

Scope:

Product Code	Product Code Name	Regulation Number
ONY	Oral removable retainer for weight management	21 CFR 876.5981
QFQ	Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss	21 CFR 876.5982
QTD	Endoscopic Suturing Device for Altering Gastric Anatomy For Weight Loss	21 CFR 876.5983

Clinical Performance Testing Considerations

Manufacturers or developers of innovative weight loss devices are required to conduct clinical studies to evaluate the safety and effectiveness of their products. Feasibility studies can serve as an initial step to gather essential safety and efficacy data for innovative device designs. These findings play a crucial role in informing pivotal studies necessary for obtaining marketing authorization. 

The following items should be considered when assessing clinical performance.

●	Study Design
●	Study Duration and Follow­up Schedule
●	Inclusion/ Exclusion Criteria
●	Patient Demographics
●	Treatment Parameters/Protocol
●	Safety and Effectiveness Endpoints and Data
●	Adverse Events
●	Statistical Analysis
●	Benefit Risk Considerations

Non-Clinical Recommendations
Non-clinical recommendations for medical devices aimed at weight management, including those for weight loss, reduction, and obesity treatment are designed to support various premarket submissions and address the diversity in device designs, weight loss outcomes, and associated risks. 

The following items align with current review practices to enhance submission consistency and streamline the review process:

1.	Device Description
2.	Labeling
3.	Sterility
4.	Pyrogenicity
5.	Shelf Life and Packaging
6.	Biocompatibility
7.	Software
8.	EMC Compatibility
9.	Wireless Technology
10.	Magnetic Resonance Compatibility for Implants
11.	Bench Performance Testing
12.	Animal Studies

For detailed information, refer to the draft guidance on the US FDA website.

 

 

References:

Medical Devices with Indications Associated with Weight Loss -Non-Clinical Recommendations

Medical Devices with Indications 2 Associated with Weight Loss - Clinical 3 Study and Benefit-Risk Considerations