Medical Device Development: Regulation and Law

Medical Device Development: Regulation and Law, 2020 Edition, is the must-have practical reference for regulatory affairs professionals. This authoritative text provides the most comprehensive and updated analysis of U.S. medical device and diagnostics development and approval requirements anywhere. The new edition offers analysis of new FDA device regulations, including all new significant guidance documents, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the United States. * Update on the new medical device provisions of the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act of 2017. * New statutory provisions and guidance documents related to regulation of software as a medical device, cybersecurity, general wellness products, real-world evidence, use of benefit risk information for both premarket and post-market processes, and when post-clearance changes require submission of a new 510(k) notice. * Update on the new TPLC organizational structure of CDRH. * Updates to the pre-submission process, including new MDUFA IV goals for meetings and feedback. * Updates to FDA's refusal to accept and review policies relating to 510(k)s, PMAs, and pre-submissions. * Update on the investigational device exemption process including new guidance documents and policies related to clinical trials, including IDE benefit-risk considerations, new Good Clinical Practices (GCPs) guidance and policy for use of foreign data, policies regarding ClinicalTrials.gov registration, as well as guidance documents on adaptive design, leveraging data for pediatric use, and demographic factors in clinical studies. * Changes to the premarket approval application process including FDA guidance on distinguishing between 30-Day Notice PMA Supplements and Site Change PMA Supplements. * New policies and guidance documents concerning in vitro diagnostic products, including updates on research and investigational use and laboratory developed tests. * Update on device compliance issues, including the 2016 medical device reporting guidance. * New guidance documents and cases relating to combination products incorporating medical devices. * New changes to FDA's review of requests for issuance of certificates to foreign governments. * FDA policy regarding the regulation of third party reprocessors.