Medical Device Design and Regulation by Carl T. DeMarco
By Carl T. DeMarco
The cause of this booklet (MDDR, for brief) is to offer an advent to, and evaluation of, the realm of clinical machine law via the USA nutrition and Drug management (FDA), and the connection of this regulatory scheme to the layout and improvement of scientific units. In offering this knowledge, the ebook covers the wide variety of necessities, that are provided inside of 8 significant themes: history and regulatory atmosphere, gadget layout regulate, nonclinical trying out, scientific trying out, advertising and marketing purposes, post-market specifications, caliber systems/GMPs, and compliance/enforcement. This ebook presents scholars and execs within the clinical machine with a highway map to the rules of clinical units. It offers a huge figuring out of the breadth and intensity of scientific machine legislation by way of accumulating in a single textbook insurance of the regulatory scheme for scientific units in phrases which are compatible for engineers, scientists, and healthcare prone. The great quantity of data on hand at the topic is distilled right into a concise and coherent presentation. There are also difficulties and tasks on the finish of every bankruptcy.
checklist of Figures and Tables
record of Abbreviations
desk of Contents
1. heritage and Regulatory surroundings
2. scientific equipment layout
three. Nonclinical trying out and GLPs
four. medical Trials
five. advertising and marketing functions
6. Post-Market necessities
7. caliber platforms and GMPs
eight. Compliance and Enforcement
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Extra resources for Medical Device Design and Regulation
Which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. Thus, state laws and regulations could supplement but not contradict the federal regulatory scheme. Congress felt that if a substantial number of 26 Chapter One differing requirements applicable to a medical device were imposed by jurisdictions other than the federal government, interstate commerce would be unduly burdened. Under this preemption provision, if a state medical device requirement were challenged in court and it was found to be in derogation of the federal regulation of medical devices, the state provision would be found to be unenforceable.
The major ones of interest in this book are: trade secrets, confidential commercial information, financially sensitive information, personal patient information, and personal employee information. It is safe to say that all medical device companies possess some protected data, and many companies possess a great deal of data and information that are considered to be privileged. The types of data and information discussed in the following sections are considered to be nonpublic and, therefore, subject to protection under company confidentiality agreements or under laws and regulations applicable to FDA employees.
FDA’s administration of the law includes many different types of actions. An important action of the FDA is the promulgation of rules and regulations. cfm Background and Regulatory Environment 21 These regulations have the full force and effect of law and they can be legally enforced by FDA through various administrative actions and judicial processes. FDA’s regulations are so important that they constitute the main concentration of the materials in this book and their application to the design, testing, manufacture, and distribution of medical devices.