21 CFR §876.5981

1. (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 use. This classification does not include devices that are intended to treat any dental diseases or conditions
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
   2. (2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
      1. (i)Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth.
      2. (ii)Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
      3. (iii)Software verification and validation must demonstrate that the device performs as intended.
      4. (iv)Battery testing must demonstrate that the device battery performs as intended.
   3. (3)Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking.
   4. (4)Device labeling must address the following:
      1. (i)Patient labeling must state:
         1. (A)The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss;
         2. (B)Treatment must be offered in combination with a behavioral modification program;
         3. (C)Instructions on how to use the device as intended; and
         4. (D)The use life of the device.
      2. (ii)Physician labeling must state:
         1. (A)The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss;
         2. (B)Treatment must be offered in combination with a behavioral modification program;
         3. (C)Instructions on how to use the device as intended; and
         4. (D)The use life of the device.
   5. (5)Training must be provided to health professionals that includes procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer.