Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Cipro and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to. Cipro may impair your thinking or reactions.
De Novo. From Latin, meaning âfrom the new.â When a court hears a case de novo, it is deciding the issues without reference to the legal conclusions or assumptions made by the previous court to hear the case.
However, many new products are not high risk. This is why the FDA has the de novo process. You may consider filing a âde novoâ submission if the FDA determines, through means such as a 513(g) or Pre-Submission, that your device is a ânovelâ with no existing classification or predicate device on the market.