Medical Devices and Radiation Emitting Products Regulation Did you know that medical devices were originally regulated under the United States Postal Statutes? That changed with enactment of the Food, Drug and Cosmetic Act. Thousands of types of medical devices exist in the market today, ranging from a simple tongue depressor to a more complex pacemaker. The Center for Devices and Radiological Health (CDRH) ...
Medical Devices and Radiation Emitting Products
Did you know that medical devices were originally regulated under the United States Postal Statutes? That changed with enactment of the Food, Drug and Cosmetic Act. Thousands of types of medical devices exist in the market today, ranging from a simple tongue depressor to a more complex pacemaker. The Center for Devices and Radiological Health (CDRH) regulates medical devices.
The goals of this volume are to: discuss the historical foundation for medical device legisla-tion as well as current pertinent legislation; provide examples of specific device classifications; provide information about medical device fundamentals, types of submissions, liability, preemp-tion, postmarket surveillance and enforcement mechanisms. Landmark cases involving the legal concept of preemption are included as well. Preemption is a legal term of art that emanates from the Supremacy Clause (Article VI, clause 2) of the United States Constitution. Article VI, clause 2 prohibits states from enacting laws that conflict with federal law unless the federal law contains explicit preemption language. Radiation emitting products regulation is also included. Each chapter contains critical analysis issues to explore.
Roseann B. Termini, B.S., Ed. M., J.D. has over twenty-five years of extensive experience in food and drug law. This volume, contained in the new print sixth edition, emanates from her comprehensive food and drug regulatory law books. Ms. Termini has frequently presented food and drug law topics as a featured speaker. Further, she has published a broad array of specialized food and drug law issues such as corporate accountability, criminal liability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General (OAG). While at the OAG, she prosecuted cases at the trial and appellate levels and was in charge of implementation procedures for the Pennsylvania Plain Language Act. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel Uni-versity and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the com-mittees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials.