AdvaMed provided comments in response to the proposed rule (Proposed Rule) regarding the Department of Health and Human Services (HHS) good guidance practices at 85 Fed. Reg. 51396 (August 20, 2020). AdvaMed commends the spirit of the proposed rule and its general framework, as it establishes requirements and a process for issuing and maintaining guidance, which promotes clarity about the full field of guidance in effect and the limitations on how such guidance may be used.