Home · Learn · Glossary

Work day vs. calendar day

FDA deadlines mix both — a "working day" excludes weekends and federal holidays, a "calendar day" doesn't.

21 CFR 803.3 (calendar day); 21 CFR 806.10 (working day)
What people get wrong

Getting this wrong is a purely avoidable way to blow a deadline. The MDR reporting window, for example, runs in calendar days, while some correction-and-removal reporting windows run in working days — the same numeric deadline ("10 days") lands on different actual dates depending on which one applies. Always confirm which one a specific regulation uses rather than assuming; don't let a long weekend quietly eat two of your working days.

Stop 12 · Screening

Not sure how this applies to your device?

Send it to us. You get the product code, the class, and whether a 510(k) is required. Free, and yours to keep.