ABSTRACT
Documentation is mandatory, resistance is futile. Paul H. King
This chapter will cover product documentation requirements in great detail, primarily from a medical device industry viewpoint. Documentation in the medical device and pharmaceutical industry is mandated in the United States under title 21 of the Code of Federal Regulations (CFR). The CFR is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration (FDA). Each title (or volume) of the CFR is revised once each calendar year. A revised title 21 is issued on approximately April 1 of each year and is posted on the FDA website in its entirety.
