ABSTRACT
Introduction ........................................................................................................170 What Is a “Law”? ...............................................................................................170 Who Makes Laws? .............................................................................................171 Who Interprets Laws? ........................................................................................171 Who Enforces Laws? .........................................................................................171 What Is the Difference between a Federal Law and a State Law? .................... 172 Which Laws Are More Important-The State or the Federal? What Is “Preemption”? ................................................................................................... 172 Are There Any Times When State Laws Control Medical Products? ................175 Where Do I Find Laws? .....................................................................................176 How Do I Find Current Laws? ...........................................................................178 What Do All These Numbers Mean? What Is a Citation? ................................ 179 What Is the Difference between the USC and the Public Laws? How Are Laws Published? ................................................................................................181 What Is the Difference between the FDCA and the USC? ................................181 What Is an “Amendment”? ............................................................................... 182 Why Can’t I Find Section 510(k) in the USC? ................................................. 183 Where Is the Biologics/Biosimilars Law? I Can’t Find It in 21 USC Anywhere .......................................................................................................... 183 What Is a “Regulation”? ................................................................................... 184 What Is the Difference between a Law and a Regulation? ............................... 184 Which Is More Important-A Law or a Regulation? ....................................... 185 What Is the Difference between the USC and the CFR? .................................. 185 How Do I Find a Current Regulation? .............................................................. 185 How Do I Find Older Regulations? .................................................................. 186 What Is “Guidance”? ........................................................................................ 186 Conclusion ........................................................................................................ 187
Working in a “regulated” environment has many connotations, but to those of us in medical products, the “regulators” always include the Food Drug and Cosmetic Act (FDCA), with its tangle of amendments and the Food and Drug Administration (FDA) itself, which issues innumerable regulations and guidances. You cannot be “in compliance” with regulations you have never read or laws you cannot find. Hence, this chapter.
