Guidance documents are documents issued by the FDA that describe the agency’s interpretation of or policy on a regulatory issue. The title of the guidance often indicates the intended audiences for the guidance, such as industry (medical device manufacturers and distributors), clinical laboratories, and FDA staff.
To address the COVID-19 public health emergency, the FDA has determined that prior public participation for the following guidance documents is not feasible or appropriate. Accordingly, the FDA issued these guidances without prior public comment.
These guidance documents are immediately in effect, but they remain subject to public comment in accordance with the FDA’s good guidance practices.