All submissions related to PPE and medical devices during the COVID-19 public health emergency are automatically tagged as a Prototype. Prototypes may not have been reviewed, and as such the reviewers from the VA Innovation Ecosystem are unable to recommend them for use, so users should exercise their best judgement in deciding to use these designs over other.

Exceptions to this initial tagging are models that:

• (a) require FDA approval or emergency use authorization, or are associated with health and safety risks
• (b) models that have already been submitted for FDA approval
• (c) designs that already have FDA emergency use authorization

Community Use is not a formal designation in classifying PPE, but we are using this term to indicate designs suitable for workers in grocery stores, restaurants, law enforcement, or in general use interacting with others. Community use designs have been tested for fit, efficiency, and reliability when the wearer is not in direct contact with a person diagnosed or suspected of having COVID-19.

This term is also not a formal designation in classifying PPE, but we have used it here to indicate when a design is appropriate for healthcare workers in contact with patients who have tested positive or show symptoms of COVID-19. Devices in this category may have different requirements and classification by the FDA.

Designs with Clinical Use status have been printed by the VA Innovation Ecosystem team and evaluated in a clinical setting. It is important to note that this applies only when they are manufactured with the printer types and materials specified. For more information on the importance of printing protocols and materials, refer to our resources page.

Not all devices require specific approval by the FDA, but there are guidelines for manufacturing and labeling that apply. They should be produced according to best practices for quality in the printing process and in selection of materials, and follow instructions provided with each design carefully through the process.

Designs with a "Warning" label are those that require FDA approval for use and/or by the nature of their design or application could introduce risks to health and safety. Users should proceed with extreme caution and