This week, the FDA issued rules on new device classifications for SARS-CoV-2 detection devices, devices that detect select microbial agents and some intravenous catheter separation devices. The agency also announced a public meeting to discuss establishment of a Rare Disease Innovation Hub and is seeking comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. HHS published a proposed regulatory agenda.