Medical Devices and Radiation Emitting Products Regulation: Food and Drug Law Book 4 of 12

by Roseann B. Termini, Esq.

Overview

The reliance on medical devices is far from a new phenomenon. The earliest attempt in the United States to regulate fraudulent medical devices was the 1872 Postal Fraud Statute, enforced by the United States Post Office and the Postmaster General. The 1906 Pure Food and Drugs Act did not provide for regulatory authority for devices. Subsequently, the 1938 Food, Drug and Cosmetic Act (FDCA) provided definitions yet was lacking in regulatory oversight such as postmarket surveillance. By 1947, there were over 460 manufacturers of surgical, medical, and dental instruments and supplies, eventually giving rise to a need for additional regulation. Currently, FDA regulates more then 190,000 devices, manufactured by over 18,000 companies in over 21,000 medical facilities worldwide. Further, approximately half of all medical devices used in the United States are imported. The Center for Devices and Radiological Health (CDRH) regulates medical devices. CDRH has the authority and responsibility for regulating companies who manufacture, repackage and relabel medical devices. This includes medical devices that are imported and sold in the United States. This responsibility and authority extends to radiation-emitting electronic products both medical and non-medical such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. The goals of this Book are to:
Discuss the historical foundation for medical device legislation as well as current pertinent legislation;
Explain how the Center for Devices and Radiological Health functions;
Detail medical device fundamentals including classifications and submissions;
Provide significant landmark United States Supreme Court decisions;
Specify personalized medicine endeavors;
Evaluate liability and preemption issues; and
Detail postmarket surveillance and enforcement mechanisms.

Landmark cases involving medical devices and 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. Radiation emitting products regulation is also included.
The distinction of how medical devices are cleared or approved is significant. There are two main types as follows: Premarket Notification generally known as a "510(k)", involves "substantial equivalence to a device already in the marketplace. The 510 (k) pre-clearance approval mechanism has not been without controversy. Yet, to that end, FDA has stepped up enforcement. The other submission type is a Premarket Application process that involves a complex review process. How a device enters the marketplace, that is whether by a Premarket Application or a Premarket Notification submission impacts the ability of a plaintiff to seek redress in state court. Legislation had been introduced to correct the inconsistency; yet it has not been enacted and doubtful in the future. A tax on medical devices was repealed in 2019.

Product Details

BN ID:	2940160996875
Publisher:	Forti Publications
Publication date:	01/08/2022
Series:	Food and Drug Law , #4
Sold by:	Barnes & Noble
Format:	eBook
File size:	323 KB

About the Author

Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. This volume, contained in the new print eighth 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. Ms. Termini was admitted in 2018 to the bar of the United States Supreme Court.