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Second, while we concurred that avoiding post-cystoscopy infections is important, we noted that none of the studies the applicant submitted as evidence evaluated or assessed the VersaVue [TM] Single-Use Flexible Cystoscope and that none of the studies compared clinical outcomes, such as adverse events (including post-cystoscopy infection) associated with the use of the VersaVue [TM] Single-Use Flexible Cystoscope to clinical outcomes associated with reusable cystoscopes

Commenters stated that publishing such small counts would not only raise HIPAA concerns but could also allow MRF users to back into sensitive information

Many communities offer medication take-back programs, and the FDA provides guidance on safe home disposal when take-back options are unavailable

The body relies on water to carry out all its functions, including circulating blood, regulating body temperature, supporting the digestive process, and enabling the organs to function at their optimal levels