Medical device regulation : FDA-CDRH manufacturing, policies and regulation handbook / Elijah Wreh.
Publication Info.
London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom : Elsevier, Academic Press, an Imprint of Elsevier, [2023]
Description based on online resource; title from digital title page (viewed on April 18, 2023).
Summary
This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices--Publisher description.
Contents
Overview of medical device regulation -- How to market a medical device -- Premarket notification [510(k)] -- Device modifications requiring new 510(k) submission -- Premarket approval (PMA) -- Investigational device exemption -- In vitro diagnostics -- Clinical studies for medical device -- Medical device labeling requirements -- FDA Medical Devices Advisory Committees -- Human factors and medical devices -- Mobile medical applications, software, and wireless coexistence -- Cybersecurity in medical devices -- Postmarket surveillance and requirements -- Compliance and enforcement -- The quality system regulation -- Risk management -- Meeting and collaboration with the FDA -- Future of the medical device industry -- Appendix: FDA guidance documents (medical devices). Regulatory affairs professionals society (RAPS). Quality management system manual -- Glossary -- Index.